Mibavademab

Dupixent® is now used to treat over a million patients globally, with continued growth and expansion in multiple indications for diseases in which type 2 inflammation plays a role EYLEA HD® and EYLEA® remained the U.S. anti-VEGF category leader in 2024; aggregate U.S. net product sales were $6 billion for full-year 2024, up 1% based on preliminary (unaudited) results EYLEA HD pre-filled syringe (PFS) submission completed; launch expected by mid-2025 Libtayo® exceeded $1 billion in 2024 annual net sales, and becomes the first and only immunotherapy to show a statistically significant clinical benefit as adjuvant therapy in high-risk cutaneous squamous cell carcinoma (CSCC) Linvoseltamab Biologics License Application (BLA) resubmitted following resolution of third-party manufacturing issues; launch anticipated mid-2025 Approximately 40 investigational candidates in industry-leading pipeline cover dozens of disease states with expansive market potential Regeneron collaborates with Truveta and leading American health systems to massively extend its DNA-linked healthcare database to further advance scientific innovation and healthcare delivery TARRYTOWN, N.Y., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today will share corporate progress and highlights from the Company’s broad and diverse investigational pipeline while presenting at the annual J.P. Morgan Healthcare Conference. The presentation is scheduled for 2:15 p.m. Pacific Time (5:15 p.m. Eastern Time) and may be accessed from the "Investors & Media" page of Regeneron's website. “The Regeneron name is synonymous with innovation, brought to life through proprietary technologies and world-class science that produce medicines that make a meaningful impact on patients’ lives,” said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. “Thanks to our long-term and consistent R&D investment, we have – in addition to our four blockbuster medicines – one of the industry’s largest, most promising and most diverse clinical pipelines. Our therapeutic candidates tackle a myriad of diseases, with the most advanced programs addressing an aggregate commercial market opportunity expected to exceed $220 billion by 2030. We are well positioned for future growth and more confident than ever in the power of Regeneron’s science.” Marketed Products Dupixent Updates Dupixent® (dupilumab) is now used to treat over a million patients globally. The recent approval and launch in chronic obstructive pulmonary disease (COPD) has had a successful start, with coverage secured from the top commercial and Medicare payers and Dupixent now well positioned to address approximately 300,000 patients in the U.S. There is continued growth potential in existing and additional indications for diseases in which type 2 inflammation may play a role, including chronic spontaneous urticaria (CSU) with an expected U.S. Food and Drug Administration (FDA) decision by April 18, 2025, and bullous pemphigoid, for which a supplemental Biologics License Application (sBLA) was submitted in the fourth quarter of 2024. EYLEA HD and EYLEA Updates On a combined basis, EYLEA HD® (aflibercept) Injection 8 mg and EYLEA® (aflibercept) Injection 2 mg remained the U.S. anti-VEGF category leader in 2024. Based on preliminary (unaudited) results, the products achieved 1% year-over-year growth by reaching $6 billion in aggregate U.S. net product sales for the year and $1.5 billion in aggregate U.S. net product sales for the fourth quarter of 2024, despite increasing competition. EYLEA HD U.S. net product sales were $305 million in the fourth quarter of 2024. EYLEA U.S. net product sales were $1.19 billion in the fourth quarter of 2024. Combined EYLEA HD and EYLEA U.S. net product sales for the fourth quarter of 2024 were favorably impacted by approximately $85 million as a result of higher wholesaler inventory levels for EYLEA, partially offset by lower wholesaler inventory levels for EYLEA HD. The Company filed an application with the FDA for use of the EYLEA HD pre-filled syringe (PFS) with U.S. approval and launch expected by mid-2025. Longer term data in wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) are under FDA review with a PDUFA date of April 20, 2025 to potentially extend dosing intervals for EYLEA HD up to every-24 weeks. The Company plans to submit a sBLA for EYLEA HD for every four-week dosing and for retinal vein occlusion (RVO) in the first quarter of 2025 to potentially maximize dosing flexibility and address more retinal diseases. Libtayo Updates Libtayo® (cemiplimab) exceeded $1 billion in sales for 2024 and remains foundational to Regeneron’s oncology portfolio. As announced this morning, a Phase 3 study demonstrated that Libtayo is the only immunotherapy to show a statistically significant and clinically meaningful benefit in high-risk cutaneous squamous cell carcinoma (CSCC) in the adjuvant setting; a recent Phase 3 trial with Keytruda® failed in the same setting.1 Specifically, adjuvant Libtayo demonstrated a 68% reduction in the risk of disease recurrence or death, compared to placebo (hazard ratio: 0.32; 95% confidence interval: 0.20-0.51; p<0.0001). Grade ≥3 adverse events occurred in 24% (n = 49 of 205) and 14% (n = 29 of 204) of patients in the Libtayo arm and the placebo arm, respectively. Detailed results will be presented at an upcoming medical meeting and will be shared with regulatory authorities with a plan for FDA submission in the first half of 2025. Phase 3 and Other Major Pipeline Opportunities Regeneron is progressing numerous promising drug candidates across diverse disease states, with advanced programs that together have a total addressable commercial market expected to exceed $220 billion by 2030. Some near-term highlights include: Itepekimab (IL-33) for COPD: Based on genetic data linking IL-33 with increased risk of COPD and Phase 2 results, Regeneron’s next innovation in COPD offers potential for benefit in a broader population, including former smokers, non-cystic fibrosis bronchiectasis and other indications. Results are expected from the Phase 3 AERIFY study in the second half of 2025, with a potential BLA submission to follow. Fianlimab (LAG3) for melanoma: Combining fianlimab and Libtayo, two potentially best-in-class checkpoint inhibitors, has the potential for differentiated efficacy and safety versus the current standard-of-care. Results from the first Phase 3 study in first-line metastatic melanoma are expected in the second half of 2025, with a potential BLA submission to follow. Linvoseltamab (BCMAxCD3) for multiple myeloma: Linvoseltamab has potential to be the best-in-class BCMAxCD3 bispecific with its differentiated clinical profile, dosing regimen and administration method. The linvoseltamab BLA has been resubmitted following resolution of third-party manufacturing issues, with launch anticipated in mid-2025. Phase 3 programs in earlier lines of therapy using linvoseltamab monotherapy and novel combinations are also underway. Odronextamab (CD20xCD3) for lymphoma: Ordspono™ (odronextamab) has been approved in the European Union for relapsed/refractory follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, and enrollment is underway for a confirmatory study to support resubmission of the BLA for FL to the FDA in the first quarter of 2025. A broad and differentiated Phase 3 program is also underway to investigate odronextamab in earlier lines of FL and DLBCL. As reported at the American Society of Hematology annual meeting, odronextamab monotherapy showed complete responses in 12 out of 12 evaluable patients with first-line FL in the safety lead-in portion of the Phase 3 program. Factor XI for anticoagulation: Regeneron’s two-pronged approach to anticoagulation is being evaluated for its potential to control thombosis while minimizing bleeding risk in a variety of patient populations and clinical settings. Two Factor XI antibodies, REGN7508 (catalytic domain) and REGN9933 (A2 domain), will advance to pivotal trials in 2025 on the basis of positive proof-of-concept data announced in December 2024. Current standards of care for thrombosis disorders have challenges including elevated risk of bleeding resulting in underutilization, presenting an unmet need for more specific inhibition of the intrinsic coagulation pathway. Multiple approaches to obesity: Regeneron is studying various combinations with GLP-based therapies to potentially improve quality of weight loss by preserving lean muscle, as well as improve maintenance of weight loss following GLP-1/GIP discontinuations. A Phase 2 study of trevogrumab and semaglutide with and without garetosmab is now fully enrolled and a Phase 2 study testing combinations of tirzepatide and mibavademab is ongoing, with initial data expected from both in the second half of 2025. BCMAxCD3/Dupixent in severe allergy: Combining linvoseltamab and Dupixent has the potential to eliminate immunoglobulin E (IgE), the key driver of allergic reactions, and thus potentially reverse severe allergies. A trial in patients with severe food allergies is ongoing, with initial clinical data shared in today’s presentation showing profound reduction of IgE in the first patient treated with this two-drug approach. C5 Combo (pozelimab and cemdisiran) in complement-mediated diseases: Regeneron’s differentiated siRNA and antibody combination approach has the potential to address multiple complement-mediated diseases, such as generalized myasthenia gravis (Phase 3 results expected in the second half of 2025), paroyxsmal noctural hemoglobinuria (Phase 3 registrational data expected in 2026+) and geographic atrophy, an advanced form of dry AMD (Phase 3 pivotal program underway). DNA Sequence-Linked Healthcare Database Regeneron continues to grow its leadership in genetics-driven drug discovery and is building the world’s largest DNA sequence-linked healthcare database, designed to unlock profound insights into how genetics impact health and aid in the development new genetic-based therapies and optimized healthcare services. The Regeneron Genetics Center® has sequenced nearly three million people to date, all with deidentified linked healthcare records. A newly announced strategic collaboration with Truveta, Inc. is expected to dramatically expand the size of this database, with sequencing and linked Electronic Health Records for up to 10 million additional individuals from Truveta’s network of leading U.S. health systems. On the basis of its industry-leading capabilities, Regeneron Genetics Center was selected by UK BioBank consortium members to complete proteomic assay data generation for the recently announced UK Biobank Pharma Proteomics Project. “Regeneron continues to diversify our commercial, clinical and research portfolios by relentlessly pushing the boundaries of innovation and technology,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer of Regeneron. “In 2025, we will progress dozens of promising new assets and expand the reach of our important established medicines to help even more patients in need. We remain at the forefront of biotechnology’s most remarkable era of drug discovery, striving to change the practice of medicine with approaches spanning antibodies, bispecifics, gene editing, gene silencing, gene therapy and cell therapy supported by DNA sequence- and proteomics-linked healthcare database.” The unapproved uses of EYLEA, EYLEA HD, Dupixent, Libtayo and pozelimab noted here are investigational and have not been fully evaluated by any regulatory authority. Cemdisiran, itepekimab, fianlimab, linvoseltamab, REGN7508, REGN9933, trevogrumab and garetosmab are investigational and have also not been fully evaluated by any regulatory authority. Odronextamab is approved in the European Union as Ordspono™ to treat R/R FL or DLBCL after two or more lines of systemic therapy, but the safety and efficacy of odronextamab has not been fully evaluated by any other regulatory authority. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X. DUPIXENT IMPORTANT SAFETY INFORMATION AND U.S. INDICATIONS DUPIXENT® (dupilumab) is a prescription medicine used: to treat adults and children 6 months of age and older with moderate-to-severe eczema (atopic dermatitis or AD) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in children with atopic dermatitis under 6 months of age. with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in adults and children 6 years of age and older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. It is not known if DUPIXENT is safe and effective in children with asthma under 6 years of age. with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults and children 12 years of age and older whose disease is not controlled. It is not known if DUPIXENT is safe and effective in children with chronic rhinosinusitis with nasal polyps under 12 years of age. to treat adults and children 1 year of age and older with eosinophilic esophagitis (EoE), who weigh at least 33 pounds (15 kg). It is not known if DUPIXENT is safe and effective in children with eosinophilic esophagitis under 1 year of age, or who weigh less than 33 pounds (15 kg). to treat adults with prurigo nodularis (PN). It is not known if DUPIXENT is safe and effective in children with prurigo nodularis under 18 years of age. with other medicines for the maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and a high number of blood eosinophils (a type of white blood cell that may contribute to your COPD). DUPIXENT is used to reduce the number of flare-ups (the worsening of your COPD symptoms for several days) and can improve your breathing. It is not known if DUPIXENT is safe and effective in children with chronic obstructive pulmonary disease under 18 years of age. Do not use if you are allergic to dupilumab or to any of the ingredients in DUPIXENT®. Before using DUPIXENT, tell your healthcare provider about all your medical conditions, including if you: have eye problems. have a parasitic (helminth) infection. are scheduled to receive any vaccinations. You should not receive a “live vaccine” right before and during treatment with DUPIXENT. are pregnant or plan to become pregnant. It is not known whether DUPIXENT will harm your unborn baby. A pregnancy registry for women who take DUPIXENT during pregnancy collects information about the health of you and your baby. To enroll or get more information call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/. are breastfeeding or plan to breastfeed. It is not known whether DUPIXENT passes into your breast milk. A pregnancy registry for women who take DUPIXENT during pregnancy collects information about the health of you and your baby. To enroll or get more information call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you are taking oral, topical, or inhaled corticosteroid medicines; have asthma and use an asthma medicine; or have atopic dermatitis, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, or chronic obstructive pulmonary disease and also have asthma. Do not change or stop your other medicines, including corticosteroid medicine or other asthma medicine, without talking to your healthcare provider. This may cause other symptoms that were controlled by those medicines to come back. DUPIXENT can cause serious side effects, including: Allergic reactions. DUPIXENT can cause allergic reactions that can sometimes be severe. Stop using DUPIXENT and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms: breathing problems or wheezing, swelling of the face, lips, mouth, tongue or throat, fainting, dizziness, feeling lightheaded, fast pulse, fever, hives, joint pain, general ill feeling, itching, skin rash, swollen lymph nodes, nausea or vomiting, or cramps in your stomach-area. Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision. Your healthcare provider may send you to an ophthalmologist for an exam if needed. Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive DUPIXENT. This may happen in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by DUPIXENT. Tell your healthcare provider right away if you have: rash, chest pain, worsening shortness of breath, a feeling of pins and needles or numbness of your arms or legs, or persistent fever. Joint aches and pain. Some people who use DUPIXENT have had trouble walking or moving due to their joint symptoms, and in some cases needed to be hospitalized. Tell your healthcare provider about any new or worsening joint symptoms. Your healthcare provider may stop DUPIXENT if you develop joint symptoms. The most common side effects include: Eczema: injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, dry eye, cold sores in your mouth or on your lips, and high count of a certain white blood cell (eosinophilia). Asthma: injection site reactions, high count of a certain white blood cell (eosinophilia), pain in the throat (oropharyngeal pain), and parasitic (helminth) infections. Chronic Rhinosinusitis with Nasal Polyps: injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, high count of a certain white blood cell (eosinophilia), gastritis, joint pain (arthralgia), trouble sleeping (insomnia), and toothache. Eosinophilic Esophagitis: injection site reactions, upper respiratory tract infections, cold sores in your mouth or on your lips, and joint pain (arthralgia). Prurigo Nodularis: eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, herpes virus infections, common cold symptoms (nasopharyngitis), dizziness, muscle pain, and diarrhea. Chronic Obstructive Pulmonary Disease: injection sites reactions, common cold symptoms (nasopharyngitis), high count of a certain white blood cell (eosinophilia), viral infection, back pain, inflammation inside the nose (rhinitis), diarrhea, gastritis, joint pain (arthralgia), toothache, headache, and urinary tract infection. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of DUPIXENT. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Use DUPIXENT exactly as prescribed by your healthcare provider. It’s an injection given under the skin (subcutaneous injection). Your healthcare provider will decide if you or your caregiver can inject DUPIXENT. Do not try to prepare and inject DUPIXENT until you or your caregiver have been trained by your healthcare provider. In children 12 years of age and older, it’s recommended DUPIXENT be administered by or under supervision of an adult. In children 6 months to less than 12 years of age, DUPIXENT should be given by a caregiver. Please see accompanying full Prescribing Information including Patient Information. EYLEA AND EYLEA HD IMPORTANT SAFETY INFORMATION AND U.S. INDICATIONS INDICATIONS EYLEA HD® (aflibercept) Injection 8 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). EYLEA® (aflibercept) Injection 2 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and Retinopathy of Prematurity (ROP) (0.4 mg). IMPORTANT SAFETY INFORMATION EYLEA HD and EYLEA are administered by injection into the eye. You should not use EYLEA HD or EYLEA if you have an infection in or around the eye, eye pain or redness, or known allergies to any of the ingredients in EYLEA HD or EYLEA, including aflibercept. Injections into the eye with EYLEA HD or EYLEA can result in an infection in the eye, retinal detachment (separation of retina from back of the eye) and, more rarely, serious inflammation of blood vessels in the retina that may include blockage. Call your doctor right away if you or your baby (if being treated with EYLEA for Retinopathy of Prematurity) experience eye pain or redness, light sensitivity, or a change in vision after an injection. In some patients, injections with EYLEA HD or EYLEA may cause a temporary increase in eye pressure within 1 hour of the injection. Sustained increases in eye pressure have been reported with repeated injections, and your doctor may monitor this after each injection. In infants with Retinopathy of Prematurity (ROP), treatment with EYLEA will need extended periods of ROP monitoring. There is a potential but rare risk of serious and sometimes fatal side effects, related to blood clots, leading to heart attack or stroke in patients receiving EYLEA HD or EYLEA. The most common side effects reported in patients receiving EYLEA HD were cataract, increased redness in the eye, increased pressure in the eye, eye discomfort, pain, or irritation, blurred vision, vitreous (gel-like substance) floaters, vitreous detachment, injury to the outer layer of the eye, and bleeding in the back of the eye. The most common side effects reported in patients receiving EYLEA were increased redness in the eye, eye pain, cataract, vitreous detachment, vitreous floaters, moving spots in the field of vision, and increased pressure in the eye. The most common side effects reported in pre-term infants with ROP receiving EYLEA were separation of the retina from the back of the eye, increased redness in the eye, and increased pressure in the eye. Side effects that occurred in adults are considered applicable to pre-term infants with ROP, though not all were seen in clinical studies. You may experience temporary visual changes after an EYLEA HD or EYLEA injection and associated eye exams; do not drive or use machinery until your vision recovers sufficiently. For additional safety information, please talk to your doctor and see the full Prescribing Information for EYLEA HD and EYLEA. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please click here for full Prescribing Information for EYLEA HD and EYLEA. LIBTAYO IMPORTANT SAFETY INFORMATION AND U.S. INDICATIONS LIBTAYO® (cemiplimab-rwlc) is a prescription medicine used to treat: People with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation. People with a type of skin cancer called basal cell carcinoma (BCC) when your BCC cannot be removed by surgery (locally advanced BCC) or when it has spread (metastatic BCC) and have received treatment with a hedgehog pathway inhibitor (HHI), or cannot receive treatment with a HHI. Adults with a type of lung cancer called non-small cell lung cancer (NSCLC). LIBTAYO may be used in combination with chemotherapy that contains a platinum medicine as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene. LIBTAYO may be used alone as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high “PD-L1,” and your tumor does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene. LIBTAYO may be used in combination with chemotherapy that contains a platinum medicine as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene. LIBTAYO may be used alone as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high “PD-L1,” and your tumor does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene. It is not known if Libtayo is safe and effective in children. IMPORTANT SAFETY INFORMATION FOR U.S. PATIENTS What is the most important information I should know about LIBTAYO? LIBTAYO is a medicine that may treat certain cancers by working with your immune system. LIBTAYO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended. Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including: Lung problems: cough, shortness of breath, or chest pain Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual, stools that are black, tarry, sticky or have blood or mucus, or severe stomach-area (abdomen) pain or tenderness Liver problems: yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach-area (abdomen), dark urine (tea colored), or bleeding or bruising more easily than normal Hormone gland problems: headache that will not go away or unusual headaches, eye sensitivity to light, eye problems, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, feeling more hungry or thirsty than usual, urinating more often than usual, hair loss, feeling cold, constipation, your voice gets deeper, dizziness or fainting, or changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, or loss of appetite Skin problems: rash, itching, skin blistering or peeling, painful sores or ulcers in mouth or nose, throat, or genital area, fever or flu-like symptoms, or swollen lymph nodes Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with LIBTAYO. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath or swelling of ankles, confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs, double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight, persistent or severe muscle pain or weakness, muscle cramps, low red blood cells, or bruising Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include: nausea, vomiting, chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain, or facial swelling Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with LIBTAYO. Your healthcare provider will monitor you for these complications Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with LIBTAYO. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with LIBTAYO if you have severe side effects. Before you receive LIBTAYO, tell your healthcare provider about all your medical conditions, including if you: have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus have received an organ transplant have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic) have received radiation treatment to your chest area have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome are pregnant or plan to become pregnant. LIBTAYO can harm your unborn baby Females who are able to become pregnant: Your healthcare provider will give you a pregnancy test before you start treatment You should use an effective method of birth control during your treatment and for at least 4 months after your last dose of LIBTAYO. Talk to your healthcare provider about birth control methods that you can use during this time Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LIBTAYO are breastfeeding or plan to breastfeed. It is not known if LIBTAYO passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of LIBTAYO Your healthcare provider will give you a pregnancy test before you start treatment You should use an effective method of birth control during your treatment and for at least 4 months after your last dose of LIBTAYO. Talk to your healthcare provider about birth control methods that you can use during this time Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LIBTAYO Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. The most common side effects of LIBTAYO when used alone include tiredness, muscle or bone pain, rash, diarrhea, and low levels of red blood cells (anemia). The most common side effects of LIBTAYO when used in combination with platinum-containing chemotherapy include hair loss, muscle or bone pain, nausea, tiredness, numbness, pain, tingling, or burning in your hands or feet, and decreased appetite. These are not all the possible side effects of LIBTAYO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Regeneron Pharmaceuticals at 1-877-542-8296. Please see full Prescribing Information, including Medication Guide. Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products") and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates") and research and clinical programs now underway or planned, including without limitation Dupixent® (dupilumab), EYLEA HD® (aflibercept) Injection 8 mg, EYLEA® (aflibercept) Injection, Libtayo® (cemiplimab), Ordspono™ (odronextamab), itepekimab, linvoseltamab, fianlimab, pozelimab in combination with cemdisiran, REGN7508, REGN9933, other of Regeneron's Product Candidates discussed or referenced in this press release, and the use of human genetics in Regeneron's research programs; the likelihood and timing of achieving any of the anticipated milestones discussed or referenced in this press release; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, including those listed above and/or otherwise discussed in this press release; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron’s Products and Regeneron’s Product Candidates; Regeneron’s expectations with respect to commercialization of Regeneron’s Products (including Dupixent, EYLEA HD, EYLEA, and Libtayo), competitive and other relevant developments affecting the market share of Regeneron’s Products, and other relevant factors (whether within or without Regeneron’s control) impacting the degree to which commercialization of Regeneron’s marketed products is successful, as well as the impact of any of the foregoing on Regeneron’s results of operations; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron’s Products and Regeneron’s Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron’s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates (including biosimilar versions of Regeneron’s Products); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees (such as those that may result from the strategic collaboration with Truveta, Inc. discussed in this press release) may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), as well as the collaboration with Truveta, Inc. discussed in this press release, to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on Regeneron's business; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA), other litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2023 and its Form 10-Q for the quarterly period ended September 30, 2024. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals). [1] Data not yet published. https://www-merck-com.libproxy1.nus.edu.sg/news/merck-provides-update-on-phase-3-keynote-867-and-keynote-630-trials/. All trademarks used are the property of their respective owners. The studies had differences in trial design specifics and no head-to-head comparisons have been conducted. Source: Regeneron Pharmaceuticals, Inc.

该篇日报由R·AI辅助创作生成，人工审核校对。 Cell子刊：微生物组与癌症免疫治疗（专家观点） Cell Reports Medicine——[14.3] ① 文章分别采访了陈豪燕、Laurence Zitvogel、彭智、Florencia McAllister等肿瘤微生物研究专家，探讨了微生物组如何影响癌症患者、治疗和临床研究；② 临床微生物组分析面临的挑战包括患者临床复杂性对微生物组的影响，饮食和环境暴露对微生物组效应的干扰，癌症治疗多样性导致难以明确治疗反应，缺乏高质量纵向微生物组数据；③ 肠道微生物组的失调影响全身炎症、免疫、代谢和神经内分泌系统，可能降低免疫治疗的效果，而通过口服复杂生态系统或活性生物制剂或可改善；④ 胃癌中，微生物组可能影响治疗反应和患者生存，特定微生物类群可能作为免疫治疗预后标志物，微生物组干预策略显示出提高治疗效果的潜力；⑤ 未来，微生物组对临床护理的影响将通过整合肿瘤基因组学、转录组学、代谢组学和微生物信息，结合人工智能指导个体化治疗。 【原文信息】 Microbiome and cancer immunotherapies 2024-04-16 , doi: 10.1016/j.xcrm.2024.101514 Cell子刊：肠道菌群与免疫治疗——前景与挑战（专家访谈） Cell Reports Medicine——[14.3] ① 这篇访谈文章中，Jennifer Wargo、Nadim Ajami和Carrie Daniel-MacDougall探讨了微生物组对癌症治疗的影响以及临床实践中的应用和挑战；② 微生物组在临床癌症治疗上具有多种潜在应用，例如通过粪菌移植、合成菌群、靶向肿瘤相关微生物和饮食营养干预等方法改善疗效，以及评估抗生素对治疗效果的影响；③ 建立微生物组分析、样本处理和数据报告的方法学标准，考虑个体差异，机构内资源最大化以促进跨学科合作，有助于克服临床转化和干预层面的挑战；④ 通过饮食干预调控肠道菌群以优化患者免疫状态和治疗反应具有前景，但在研究和实施中也存在复杂性和可持续性等挑战。 【原文信息】 Jennifer A. Wargo, Nadim J. Ajami, and Carrie R. Daniel-MacDougall 2024-04-16 , doi: 10.1016/j.xcrm.2024.101509 李雪团队：空气污染与结直肠癌风险的表观遗传学关联 EBioMedicine——[11.1] ① 空气污染会改变宿主免疫系统、改变表观遗传学标记，但其如何通过影响表观遗传学介导结直肠癌（CRC）进程尚未解析，浙江大学医学院李雪与团队基于UK BioBank临床数据和孟德尔随机化对其进行了研究；② 从UK Biobank纳入了428632名受试者及其临床数据和环境报告，基于PM10、PM2.5、NOx、NO2数据引入空气污染暴露评分（APES），发现高APES与增加的CRC风险和较差的生存率相关，尤其是在体力活动不足和吸烟者中表现明显；③ 对之前PM2.5与CRC风险研究进行荟萃分析，证实了PM2.5暴露增加与CRC风险升高的关联；④ 结合孟德尔随机化和GWAS分析发现PM2.5相关的 TMBIM1/PNKD 基因、 CXCR5基 因、NO2相关的 TMEM110 基因甲基化位点与CRC风险增加相关；⑤ 通过基因-环境互作分析验证了与PM2.5和NO2暴露相关的甲基化位点与CRC风险和死亡率增加的关联。 【原文信息】 Impact of ambient air pollution on colorectal cancer risk and survival: insights from a prospective cohort and epigenetic Mendelian randomization study 2024-04-16 , doi: 10.1016/j.ebiom.2024.105126 国内团队：XELOX+贝伐单抗+PD1-T联用，或可作为转移性大肠癌一线治疗方案 Signal Transduction and Targeted Therapy——[39.3] ① 郑州大学的张毅、苏州大学的蒋敬庭、天津医科大学的任秀宝和中山大学的夏建川团队合作发表了一项3期临床结果，在未经治疗的转移性结直肠癌（mCRC）患者中，PD-1阻断激活的DC-CIK（PD1-T）细胞联合XELOX和贝伐珠单抗作为一线治疗，显示出显著的PFS和OS临床改善，并且耐受性良好；② 招募202名参与者，随机接受XELOX+贝伐单抗（对照组）或相同方案加自体PD1-T细胞免疫治疗，每21天一次，最多6个疗程，随后进行卡培他滨和贝伐单抗的维持治疗；③ 中位随访期19.5个月，免疫疗法组的中位无进展生存期（PFS）为14.8个月，显著优于对照组的9.9个月；④ 免疫疗法组的中位总生存期（OS）尚未达到，而对照组为25.6个月；⑤ 两组患者中3级或更高级别的不良事件（AEs）发生率相近，免疫疗法组为20.0%，对照组为23.5%，未报告与毒性相关的死亡。 【原文信息】 XELOX (capecitabine plus oxaliplatin) plus bevacizumab (anti-VEGF-A antibody) with or without adoptive cell immunotherapy in the treatment of patients with previously untreated metastatic colorectal cancer: a multicenter, open-label, randomized, controlled, phase 3 trial 2024-04-03 , doi: 10.1038/s41392-024-01788-2 中山六院：新辅助化疗——局部晚期结肠癌的可行治疗选择 Journal of Clinical Oncology——[45.3] ① 中山大学附属第六医院邓艳红与团队发表临床研究OPTICAL，这是一项随机对照3期试验，旨在评估新辅助化疗在局部晚期结肠癌中的作用；② 共纳入752例临床局部晚期结肠癌患者，按照1:1随机分为6周期mFOLFOX6或4周期CAPOX，随后手术与辅助化疗（NAC组），或即刻手术与医师选择辅助化疗（直接手术组）；③ .平均48个月的随访中，NAC组的3年无病生存期率为82.1%，而直接手术组为77.5%；④ 相比直接手术组，NAC组实现了7%的病理完全缓解率，降低了高级别肿瘤分期和淋巴结转移的比例；⑤ NAC组的整体生存率可能有所提高，显示出新辅助化疗是一种可行的治疗选择。 【原文信息】 Neoadjuvant Chemotherapy With Oxaliplatin and Fluoropyrimidine Versus Upfront Surgery for Locally Advanced Colon Cancer: The Randomized, Phase III OPTICAL Trial 2024-04-02 , doi: 10.1200/JCO.23.01889 Nature子刊：SMARCB1是结直肠癌分化的负调控因子 Nature Communications——[16.6] ① 本研究通过构建双内源报告系统，成功鉴定了影响结直肠癌（CRC）中干细胞样活性和分化障碍的关键调控因子，为开发新的治疗策略提供了可能；② 通过基因编辑技术在人类CRC细胞系的SOX9和KRT20位点引入荧光报告基因，用以监测干细胞样活性和异常的分化；③ 通过针对78个表观遗传调控因子的CRISPR筛选，识别出影响CRC干细胞样活性和分化的因子；④ 经过Perturb-seq验证的结果显示，BAF复合体的成员SMARCB1是多种结肠肿瘤模型中分化的负调控因子，且对人类CRC模型在体内生长是必需的。 【原文信息】 Identifying regulators of aberrant stem cell and differentiation activity in colorectal cancer using a dual endogenous reporter system 2024-03-12 , doi: 10.1038/s41467-024-46285-w 9种有效改善结肠镜检查质量的干预措施 Gastroenterology——[29.4] ① 本研究通过网络荟萃分析，纳入124项试验，评估了37种干预措施对提高筛查相关结肠镜检查质量的相对效果，发现九种干预措施能显著提高腺瘤检出率（ADR）；② 这些干预措施包括9分钟撤退时间、双重观察、水交换、iScan™、联合色彩成像、计算机辅助检测、Endocuff™、Endocuff Vision™和口服亚甲蓝；③ 在提高ADR方面，双重观察和水交换在术中技术中排名最高，iScan™、联合色彩成像和计算机辅助检测在内窥镜技术中排名最高，WingCap和Endocuff™在远端附件设备中排名最高，口服亚甲蓝在添加剂中排名最高；④ 没有干预措施能改善高级腺瘤的检测，狭窄带成像是唯一一种能提高锯齿状病变检出率的干预措施；⑤ 结果显示，一些干预措施在改善腺瘤检测和结肠镜检查质量方面是有效的，其中许多是免费的，这些结果为内镜医师、单位管理者和内镜学会提供了关于各种干预措施相对效果的信息。 【原文信息】 Relative Efficacies of Interventions to Improve the Quality of Screening-related Colonoscopy: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials 2024-03-19 , doi: 10.1053/j.gastro.2024.03.018 北京协和医院：问卷+FIT策略进行结肠镜筛查更经济高效 PLoS Medicine——[15.8] ① 北京协和医学院的李霓和赫捷团队合作发表文章，发现基于问卷调查收集风险因素数据（RF策略）和粪便免疫化学试验结果（RF-FIT策略）相结合进行结直肠癌筛查，参与度、经济性和检出率方面更好；② CanSPUC和WHOLE队列分别采用RF和RF-FIT策略，RF-FIT组和RF组有71,967人（7.65%）和281,985人（18.47%）被识别为高风险，被邀请接受结肠镜检查；③ RF-FIT和RF组的结肠镜参与率为26.50%和19.54%，RF-FIT检出102例（0.53%）结直肠癌和2,074例（10.88%）高级别腺瘤，而RF检出90例（0.16%）结直肠癌和3,593例（6.52%）高级别腺瘤；④ RF-FIT策略的早期检出率显著高于RF策略（67.05% vs47.95%）；⑤ RF-FIT策略每检出一例结直肠癌的成本为24,849美元，而RF策略为55,846美元。 【原文信息】 Combining fecal immunochemical testing and questionnaire-based risk assessment in selecting participants for colonoscopy screening in the Chinese National Colorectal Cancer Screening Programs: A population-based cohort study 2024-02-22 , doi: 10.1371/journal.pmed.1004340 2024年欧洲癌症死亡率预测及结肠癌趋势 Annals of Oncology——[50.5] ① 该研究预测，2024年欧盟和英国的癌症死亡率及结直肠癌死亡率呈整体降低趋势，但年轻人的结直肠癌死亡率呈增加趋势；② 预测显示，2024年欧盟的癌症死亡人数为1,270,800例，自2018年，男性癌症死亡率下降6.5%至123.2/10万人，女性下降4.3%至79.0/10万人；③ 自1988年，欧盟及英国分别避免了约620万例及130万例癌症死亡；④ 欧盟及英国男性的各年龄段的结直肠癌死亡率均下降，自2018年，男性及女性分别降低4.8%及9.5%，但50岁以下的结直肠癌死亡率呈不利趋势；⑤ 胰腺癌和女性肺癌的死亡率呈不利趋势；⑥ 该结果对癌症防控和公共卫生政策具有指导意义。 【原文信息】 European cancer mortality predictions for the year 2024 with focus on colorectal cancer 2024-01-17 , doi: 10.1016/j.annonc.2023.12.003 药物预防和治疗癌症患者阿片类药物引起的便秘（荟萃分析） Cancer Treatment Reviews——[11.8] ① 本研究比较了预防或治疗癌症患者由于阿片类药物引起的便秘（OIC）的药物策略，发现氧化镁和纳地美定对预防OIC有效，而纳洛酮+羟考酮和纳地美定+甲基纳曲酮的组合对治疗OIC有效，且副作用可接受；② 在预防OIC方面，氧化镁与无泻药相比、纳地美定与氧化镁相比，效果更显著，但是羟考酮+纳洛酮与羟考酮或芬太尼相比未显示出显著差异；③ 在治疗OIC方面，聚乙二醇与番泻叶甙相比、羟考酮+纳洛酮与羟考酮+泻药相比、纳地美定+甲基纳曲酮与安慰剂相比，均显示出显著改善效果，羟考酮+纳洛酮更容易引起恶心；④ 在不良事件方面，使用甲基纳曲酮治疗的患者腹痛较多，使用纳地美定治疗的患者腹泻较多，不同剂量甲基纳曲酮的疗效和不良事件发生率无显著差异；⑤ 尽管这些药物显示出对OIC的预防和治疗有效，但与标准泻药（渗透性或刺激性泻药）尚缺乏比较，需要更多研究以应用于临床。 【原文信息】 Pharmacological prevention and treatment of opioid-induced constipation in cancer patients: A systematic review and meta-analysis 2024-03-01 , doi: 10.1016/j.ctrv.2024.102704 四川厌氧生物与皇氏乳业达成战略合作 ① 4月18日，四川厌氧生物科技有限责任公司与皇氏乳业集团签订战略合作协议；② 双方将共同研发适合中国市场的酸奶发酵剂和益生功能菌株，提升皇氏酸奶产品的口感和营养价值；③ 合作将推动我国乳业科技进步和产业升级，双方将在技术研发、市场拓展等方面深化合作；④ 皇氏乳业集团是一家全产业链发展的上市公司，致力于水牛奶产业；⑤ 四川厌氧生物专注于微生态药物开发，拥有完整的“从菌到药”核心技术和资源库。 【原文信息】 四川厌氧生物与皇氏乳业集团达成战略合作！ 2024-04-19 , 厌氧生物 胃球囊减肥产品公司「Allurion」获得4800万美元融资 ① 4月17日，Allurion公司宣布完成了一笔价值4800万美元（约合人民币3.48亿元）的票据融资；② 融资由RTW Investments领衔的机构投资者完成；③ 资金将用于帮助Allurion公司偿还债务，以及推进其AUDACITY临床研究；④ Allurion公司开发了一种无需手术、内窥镜或麻醉的可吞咽胃球囊用于减肥，胃球囊在吞咽4个月后可自动排出体外；⑤ 目前，临床研究已证实了该产品的减肥功效。 【原文信息】 Allurion closes $48 million financing 2024-04-17 , Mass Device 礼来携手再生元启动替尔泊肽+Mibavademab减肥2期临床研究 ① 4月18日，礼来与再生元启动了替尔泊肽联合LEPR抗体Mibavademab治疗肥胖的2期临床试验；② 该试验计划招募360例肥胖患者，旨在探索LEPR抗体是否能增强替尔泊肽的减重效果；③ 1期临床显示，Mibavademab对瘦素水平低的肥胖患者有显著减重效果，对瘦素水平高的人群没有减重效果；④ 减重市场的火爆引发众多公司投身该领域，再生元结合基因药物中心发现了大量潜在新靶点，包括GPR75和INHBE等。 【原文信息】 礼来携手再生元：替尔泊肽+LEPR抗体启动减肥二期临床 2024-04-19 , 医药笔记 特瑞药业司美格鲁肽注射液减肥适应证获批临床 ① 4月19日，苏州特瑞药业宣布，旗下司美格鲁肽注射液用于体重管理适应证获批临床；② 特瑞药业成为该药2.2类全国第三家获批单位，成功跻身第一梯队；③ 此前，石药集团和华润双鹤司美格鲁肽注射液体重管理适应证获得了临床批准；④ 特瑞药业积极致力于保护公众健康，提高药品可及性，未来将努力研发和生产高质量仿制药品。 【原文信息】 减重适应症第一梯队！特瑞药业司美格鲁肽注射液体重控制适应症获批临床 2024-04-19 , 特瑞药业 NRx公布NRX-101临床前积极数据 ① 5月17日，NRx Pharmaceuticals公司对外表示，其抗生素产品NRX-101在啮齿动物模型中对肠道和阴道菌群无明显损害，与标准抗生素相比有潜在优势；② 标准抗生素产品如环丙沙星容易引起复杂尿路感染以及伪膜性肠炎；③ NRX-101的主要成分为D-环丝氨酸并在小肠完成吸收，未代谢成分通过尿液排出，可减少艰难梭菌或阴道酵母菌感染的风险；④ 目前，NRX-101已被FDA认定为合格传染病产品，在复杂尿路感染及肾盂肾炎上获得了快速通道资格认定。 【原文信息】 NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announces New Data on NRX-101 Demonstrating No Damage to Intestinal and Vaginal Flora in Validated Rodent Models Compared to Standard Antibiotics: Potential Implications for Avoidance of C. Difficile infections 2024-04-17 , PR Newswire 感谢本期日报的审核者：mildbreeze，Johnson，章台柳，九卿臣，aluba，RZN，Richard 点击阅读过去10天的日报： 0421 | 以食为药：10文聚焦疾病中的饮食干预 0420 | Science揭秘：肠道中的噬菌体-病菌"军备竞赛" 0419 | 程功/朱毅斌/王静林等Science突破：巧用共生菌，阻断蚊媒病毒传播 0418 | 聚焦特殊人群：母婴肠道菌群与健康 0417 | 高分Nature子刊：汇集全球玩家力量，助力肠道微生物研究 0416 | 多文聚焦：保卫肠道，免疫细胞和菌群谁都不能少 0415 | Cell重磅综述：系统解析癌症复杂性，菌群作用不容小觑 0414 | 高分Cell子刊综述，一文讲透发酵食品 0413 | 3篇子刊重磅文章，解析微生物组治疗的现状与未来 0412 | 10文聚焦国内团队新成果，肠道和菌群研究多点开花