Infliximab-dyyb (Celltrion)

Pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC) previously demonstrated superior efficacy of subcutaneous (SC) infliximab over placebo for maintenance therapy in patients with Crohn's disease (CD) and ulcerative colitis (UC)[1], [2] ZYMFENTRA® is the first and only FDA-approved subcutaneous infliximab Late-breaking post hoc analysis of the LIBERTY studies suggests no meaningful differences in efficacy and safety outcomes at week 54 and 102 weeks between monotherapy and combination therapy of SC infliximab with immunosuppressants[3] JERSEY CITY, N.J., Oct. 29, 2024 /PRNewswire/ -- Celltrion USA today announced a late-breaking post hoc analysis of the pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC) of ZYMFENTRA® (infliximab-dyyb), during the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting. The data demonstrate that clinical outcomes for patients treated with ZYMFENTRA monotherapy were comparable to those for patients on combination therapy with immunosuppressants (IS), suggesting that monotherapy could be a potential treatment option for patients with inflammatory bowel disease (IBD).[3] One-year data for the LIBERTY studies were originally published in the journal Gastroenterology.[4] ZYMFENTRA, the first and only FDA-approved subcutaneous infliximab, had previously shown superior efficacy over placebo for maintenance therapy in patients with Crohn's disease (CD) and ulcerative colitis (UC) in the randomized LIBERTY-CD and LIBERTY-UC studies.[1], [2] The new post hoc analysis explored the impact of baseline IS use by comparing outcomes between monotherapy and combination therapy.[3] The analysis included 429 patients from the CD and UC cohorts across the LIBERTY studies (192 patients with CD [monotherapy, n=126; combination therapy, n=66] and 237 patients with UC [monotherapy, n=180; combination therapy, n=57]). In both studies, there were no meaningful differences in efficacy outcomes between monotherapy and combination therapy at Week 54 or Week 102, despite combination therapy generally showing higher mean trough levels of infliximab after Week 10. Additionally, the overall safety profile was comparable between monotherapy and combination therapy throughout the pooled maintenance and extension phase.[3] "The new data strengthens the case for ZYMFENTRA monotherapy as a potential treatment option for patients with Crohn's disease and ulcerative colitis," said Hetal Patel, PharmD MBA, Head of Medical Affairs at Celltrion USA. "At Celltrion, we are committed to offering therapies that help patients and healthcare providers make informed, personalized treatment decisions. These findings suggest that ZYMFENTRA could offer flexibility in treatment approaches, providing confidence in monotherapy as an alternative to combination therapy, while maintaining effective disease control." About Celltrion USA Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has five biosimilars approved by the U.S. FDA: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd) and YUFLYMA®(adalimumab-aaty) as well as a new biologic ZYMFENTRA®. Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit: . About ZYMFENTRA® (infliximab-dyyb) ZYMFENTRA is a prescription medicine used as an injection under the skin (subcutaneous injection) by adults for the maintenance treatment of: Moderately to severely active ulcerative colitis following treatment with an infliximab product given by intravenous infusion (IV) and moderately to severely active Crohn's disease following treatment with an infliximab product given by intravenous infusion (IV). ZYMFENTRA blocks the action of tumor necrosis factor-alpha (TNF-alpha), a protein that can be overproduced in response to certain diseases and cause the immune system to attack normal, healthy parts of the body. ZYMFENTRA (infliximab-dyyb) was approved by the FDA through the Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act (a "stand-alone" BLA). ZYMFENTRA is a self-injected form of infliximab and thus will be under patent protection for its dosage form by 2037 and for its route of administration by 2040. ZYMFENTRA ® (infliximab-dyyb) U.S. Use and Important Safety Information ZYMFENTRA is a prescription medicine indicated in adults for maintenance treatment of: Moderately to severely active Crohn's disease following treatment with an infliximab product administered intravenously. Moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously. It is not known if ZYMFENTRA is safe and effective in children under 18 years of age. What is the most important information I should know about ZYMFENTRA? SERIOUS INFECTIONS Patients treated with ZYMFENTRA are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before and during treatment with ZYMFENTRA. Treatment for latent infection should be initiated prior to treatment with ZYMFENTRA. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients may present with disseminated, rather than localized, disease. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. The risks and benefits of treatment with ZYMFENTRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with ZYMFENTRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Risk of infection may be higher in patients greater than 65 years of age, patients with comorbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with infliximab included arthritis bacterial, pneumonia, and urinary tract infection. MALIGNANCIES Malignancies, some fatal, have been reported in children, adolescents, and young adults treated with TNF blockers, including infliximab products. Approximately half of these cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants. Post-marketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including infliximab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported cases have occurred in patients with Crohn's disease or ulcerative colitis, and most were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treatment with ZYMFENTRA, especially in these patient types. In clinical trials of all TNF blockers, more cases of malignancies were observed compared with controls and the expected rate in the general population. In clinical trials of some TNF blockers, including infliximab products, more cases of other malignancies were observed compared with controls. As the potential role of TNF blocker therapy in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy. Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including infliximab products. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. CONTRAINDICATIONS ZYMFENTRA is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab-dyyb, other infliximab products, any of the inactive ingredients of ZYMFENTRA or any murine proteins (severe hypersensitivity reactions have included anaphylaxis, hypotension, and serum sickness). HEPATITIS B VIRUS REACTIVATION TNF blockers, including infliximab products, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating ZYMFENTRA. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing ZYMFENTRA for patients identified as carriers of HBV, and monitor closely for active HBV infection during and following termination of therapy with ZYMFENTRA. Discontinue ZYMFENTRA in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of ZYMFENTRA, and monitor patients closely. HEPATOTOXICITY Hepatobiliary disorders, including acute liver failure, jaundice abnormal hepatic function, hepatic steatosis, hepatitis, hepatotoxicity, hyperbilirubinemia, and non-alcoholic fatty liver, have been reported in patients receiving infliximab products post-marketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, ≥5 times the upper limit of normal) develop, ZYMFENTRA should be discontinued, and a thorough investigation of the abnormality should be undertaken. CONGESTIVE HEART FAILURE Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. Some cases had a fatal outcome. In several exploratory trials of other TNF blockers in the treatment of CHF, there were greater proportions of TNF-blocker-treated patients who had CHF exacerbations requiring hospitalization or increased mortality. ZYMFENTRA has not been studied in patients with a history of CHF and ZYMFENTRA should be used with caution in patients with CHF. HEMATOLOGIC REACTION Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia (some fatal) have been reported. The causal relationship to infliximab-product therapy remains unclear. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Consider discontinuation of ZYMFENTRA in patients who develop significant hematologic abnormalities. HYPERSENSITIVITY AND OTHER ADMINISTRATION REACTIONS In post-marketing experience, serious systemic hypersensitivity reactions (including anaphylaxis, hypotension, and serum sickness) have been reported following administration of infliximab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue ZYMFENTRA. INJECTION SITE REACTIONS In clinical studies, localized injection-site reactions were reported following administration of ZYMFENTRA. If a clinically significant injection-site reaction occurs, institute appropriate therapy and discontinue ZYMFENTRA. NEUROLOGIC REACTIONS Agents that inhibit TNF have been associated with central nervous system (CNS) manifestation of systemic vasculitis, seizure, and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exercise caution when considering ZYMFENTRA in patients with these disorders and consider discontinuation if these disorders develop. RISK OF INFECTION WITH CONCURRENT ADMINISTRATION OF OTHER BIOLOGICS PRODUCTS Serious infections and neutropenia have been reported with concurrent use of ZYMFENTRA with other immunosuppressive biological products. The concurrent use of ZYMFENTRA with other immunosuppressive biological products used to treat UC and CD may increase the risk of infection and is not recommended. RISK OF ADDITIVE IMMUNOSUPPRESSIVE EFFECTS FROM PRIOR BIOLOGICAL PRODUCTS Consider the half-life and mode of action of prior biological products to avoid unintended additive immunosuppressive effects when initiating ZYMFENTRA. AUTOIMMUNITY Treatment with TNF blockers may result in the formation of autoantibodies and in the development of a lupus-like syndrome. Discontinue ZYMFENTRA treatment if symptoms of a lupus-like syndrome develop. VACCINATIONS AND USE OF LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTS Prior to initiating ZYMFENTRA, update vaccinations in accordance with current vaccination guidelines. Live vaccines or therapeutic infectious agents should not be given with ZYMFENTRA due to the possibility of clinical infections, including disseminated infections. At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to ZYMFENTRA. ADVERSE REACTIONS In clinical trials with ZYMFENTRA, the most common adverse reactions occurring in ≥3% of ZYMFENTRA -treated patients included site reactions, COVID-19, anemia, arthralgia, infection site reaction, increased alanine aminotransferase and abdominal pain for UC, and COVID-19, headache, upper respiratory tract infection, injection site reaction, diarrhea, increased blood creatine phosphokinase, arthralgia, increased alanine aminotransferase, hypertension, urinary tract infection, neutropenia, dizziness and leukopenia for CD. Please click for Full U.S. Prescribing Information. Globally, prescribing information varies; refer to the individual country product label for complete information. References For further information please contact: Samantha Cranko [email protected] +1 917-453-0346 SOURCE Celltrion USA WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

全球药物批准/研发动态 01 全球新药批准情况 根据药渡数据统计分析，本次统计周期（2024.10.12-10.18）全球（不含中国）共有6个新药获批上市。其中，BLA批准2个，新适应症批准4个。与上个统计周期相比，本次增加2个批准新药。 10月15日，君实生物宣布抗PD-1单抗药物特瑞普利单抗的上市申请已先后在印度和中国香港获批上市，用于复发/转移性鼻咽癌的治疗。此次获批的适应症分别为：1）特瑞普利单抗联合顺铂/吉西他滨作为转移性或复发性局部晚期鼻咽癌成人患者的一线治疗；2）特瑞普利单抗单药治疗既往含铂治疗过程中或治疗后疾病进展的复发性、不可切除或转移性鼻咽癌的成人患者。研究结果显示，特瑞普利单抗联合化疗使患者的疾病进展风险降低48%，死亡风险降低37%，PFS对比单纯化疗延长了13.2个月。 10月18日，德琪医药宣布，MFDS已批准希维奥®（塞利尼索片）的补充新药上市申请，联合硼替佐米和地塞米松用于治疗至少接受过一种先前治疗的多发性骨髓瘤成人患者。塞利尼索片是一款全新机制的口服选择性核输出蛋白（XPO1）抑制剂。通过抑制核输出蛋白XPO1，该产品可促使肿瘤抑制蛋白和其他生长调节蛋白的核内储留和活化，并下调细胞浆内多种致癌蛋白水平。 全球（不含中国）新药批准情况（部分） 02 全球新药申报进展 根据药渡数据统计分析，本次统计周期（2024.10.12-10.18）全球（不含中国）共有10个新药申报上市。其中，NDA申报8个，BLA申报2个。与上次统计周期相比，本次增加4个NDA/BLA申报。 10月15日，恒瑞医药公告称其重新提交的注射用卡瑞利珠单抗联合甲磺酸阿帕替尼片用于不可切除或转移性肝细胞癌患者的一线治疗的BLA获得FDA受理。研究结果显示，此疗法具有显著的生存获益和可耐受的安全性，中位PFS为5.6个月，中位OS达到23.8个月。 NDA/BLA申报（部分） 根据药渡数据统计分析，本次统计周期（2024.10.12-10.18）全球（不含中国）共有4个药物获监管机构特殊资格认定。其中，化学药2个，生物药1个，疫苗1个。与上次统计周期相比，本次减少2个获监管机构特殊资格认定的药物。 10月15日，Immuneering宣布FDA已授予IMM-1-104孤儿药资格认定，用于治疗胰腺癌。IMM-1-104旨在通过每日一次给药对MAPK通路的深度循环抑制，实现普遍的RAS活性，即选择性地影响癌细胞。IMM-1-104目前正在晚期实体瘤（包括胰腺癌）患者中进行IIa期临床试验，其中最近报道了联合改良吉西他滨/白蛋白结合型紫杉醇治疗的一线胰腺癌患者的阳性初始反应数据。 10月16日，Theriva Biologics宣布EMA已授予VCN-01孤儿药产品资格，用于治疗视网膜母细胞瘤。VCN-01是一种全身给药的溶瘤腺病毒，旨在选择性和侵袭性地在肿瘤细胞内复制并降解肿瘤基质。这种独特的作用方式使VCN-01能够通过以下方式发挥多种抗肿瘤作用：（i）选择性感染和裂解肿瘤细胞;（ii）加强联合给药化疗产品的可及性和灌注;（iii）增加肿瘤免疫原性并使肿瘤暴露于患者的免疫系统和联合给药的免疫治疗产品。全身给药使VCN-01能够对原发肿瘤和转移瘤发挥作用。 特殊资格认定情况（部分） 03 全球新药研发进展 根据药渡数据统计分析，本次统计周期（2024.10.12-10.18）全球（不含中国）新药临床研发状态更新共计46条，涉及肿瘤、血液和淋巴疾病、遗传代谢病、神经疾病以及免疫系统疾病等共计13个领域。 其中，感染领域临床进展更新居各领域之首，为10条：涉及化学药3条，生物药3条，细胞疗法2条。 10月15日，Celltrion公布了皮下注射英夫利昔单抗（CT-P13 SC）的2年事后分析结果，强调剂量递增是管理炎症性肠病反应丧失的一种选择。分析表明，对于最初有反应但随后失去反应的患者，静脉内（IV）诱导后CT-P13 SC的剂量递增在102周的延长时间内显示出临床疗效，患者UC的平均改良Mayo评分和CD的平均CDAI评分具有统计学意义降低。 10月16日，长春高新发布公告称，其子公司金赛药业GenSci122片项目获得FDA新药临床试验默示许可。GenSci122是具有新型结构的小分子KIF18A抑制剂，KIF18A抑制剂与染色体不稳定（CIN）及全基因组加倍（WGD）+构成合成致死。与正常二倍体细胞相比，KIF18A在CIN肿瘤细胞中高表达，具有CIN特性的肿瘤细胞对KIF18A具有依赖性。靶向抑制KIF18A可作为肿瘤的潜在治疗策略，同时不会显著影响正常二倍体细胞的增殖。 全球新药研发进展详情（部分） 04 全球医药交易事件 本次统计周期（2024.10.12-10.18）全球（含中国）医药交易时间共计33起，涉及药物权益转让、公司并购等多起交易事件。 全球医药交易时间汇总表（部分） 国内药物批准/研发动态 01 国内新药批准情况 根据药渡数据统计分析，本次统计周期（2024.10.12-10.18）国内共有4个新药获NMPA批准上市。其中，BLA批准1个，新适应症批准3个。与上次统计周期相比，本次减少4个NMPA批准新药。 10月14日，NMPA官网公示，Roche的法瑞西单抗（Faricimab）注射液新适应症上市申请获得批准，用于治疗视网膜中央静脉阻塞（CRVO）继发黄斑水肿。法瑞西单抗可同时靶向阻断两条致病关键通路，在原有抑制新生血管生成的基础上同时提高血管稳定性，降低血管异常渗漏，改善患者的视力。研究表明，对于由CRVO引起的黄斑水肿患者，每4周接受法瑞西单抗注射（长达24周）视力获得具有非劣效性，从基线到第24周，法瑞西单抗能使患者的视网膜液迅速干燥。 10月14日，NMPA官网公示由Daiichi Sankyo申报的注射用德曲妥珠单抗（Enhertu）已经获得上市批准，用于治疗存在HER2激活突变且既往接受过至少一种系统治疗的不可切除或转移性成人非小细胞肺癌（NSCLC）患者。研究结果显示，在既往经治HER2突变NSCLC中国患者中实现ORR近60%，DCR超过91%，多个疗效指标显示德曲妥珠单抗带来了具有临床意义和持久的缓解，而且安全性可控。 国内新药批准情况（部分） 02 国内新药临床默示许可进展 根据药渡数据统计分析，本次统计周期（2024.10.12-10.18）国内共有59个新药获临床默示许可，涉及100个受理号。其中，化学药29个，治疗用生物制品28个，预防用生物制品2个。与上次统计周期相比，本次增加66个临床默示许可获批受理号。 本周国内新药临床默示许可进展（部分） 03 国内新药申报进展 根据药渡数据统计分析，本次统计周期（2024.10.12-10.18）国内共有18个新药申报上市，涉及29个受理号。其中，化药8个，治疗用生物制品8个，预防用生物制品2个。与上个统计周期相比，本次增加9个新药申报上市受理号。 国内新药申报上市情况（部分） 根据药渡数据统计分析，本次统计周期（2024.10.12-10.18）国内共有67个新药申报临床，涉及100个受理号。其中，化学药36个，治疗用生物制品30个，预防用生物制品1个。与上次统计周期相比，本次增加69个临床申报受理号。 国内新药临床申报情况（部分） 根据药渡数据统计分析，本次统计周期（2024.10.12-10.18）国内共有4个药物获NMPA特殊资格认定。其中，化学药1个，生物药2个，疫苗1个。与上次统计周期相比，本次增加3个获监管机构特殊资格认定的药物。 10月15日，NMPA药品审评中心官网最新公示，和其瑞医药申报的1类新药HMI-115拟纳入突破性治疗品种，适应症为治疗子宫内膜异位症相关的中重度疼痛。HMI-115是一款靶向泌乳素受体（PRLR）的单抗新药，PRLR表达失调可能与子宫内膜异位症的发病机制有关，而靶向催乳素和催乳素受体的药物可能改善和控制该疾病相关的疼痛。研究公示信息显示，HMI-115的给药方式为皮下给药，只需每2周一次，共6个治疗周期。 同日，NMPA药品审评中心官网公示南京远大赛威信生物医药有限公司申报的1类新药TVAX-008注射液拟纳入突破性治疗品种，适用于治疗慢性乙型肝炎病毒（HBV）感染。TVAX-008利用多靶点乙肝表面抗原（HBsAg）和HBcAg联合CpG寡聚脱氧核苷酸佐剂，其中HBsAg/HBcAg促进体液免疫，恢复Th1/Th2平衡；CpG激活B细胞和pDC的TLR9，诱导针对乙肝病毒的细胞免疫。该产品可通过不同途径呈递乙肝抗原，打破机体的免疫耐受，有效诱导免疫应答，从而达到治疗和控制慢性乙肝感染的效果。 国内监管机构特殊资格认定药物 04 国内新药研发进展 根据药渡数据统计分析，本次统计周期（2024.10.12-10.18）国内新药临床研发状态更新共计4条，涉及肿瘤、消化系统、遗传和代谢疾病以及皮肤病共计4个领域。其中，化学药1条，生物药3条。与上次统计周期相比，本次减少2条国内新药临床研发状态更新。 10月13日，博瑞医药宣布BGM0504在非糖尿病的超重或肥胖受试者中开展的II期临床试验，达到主要终点和关键次要终点。BGM0504是一款靶向胰高血糖素样肽1（GLP-1）和葡萄糖依赖性促胰岛素多肽（GIP）受体双重激动剂，每周给药一次。非糖尿病24周平均减重18.5%和减腰围13.4cm，并显著降低多项心血管代谢风险指标，增加胰岛素敏感性，耐受性和安全性良好。 10月17日，信达生物宣布匹康奇拜单抗（IL-23p19抗体）治疗溃疡性结肠炎的II期临床研究达成主要终点：诱导治疗期第12周时，匹康奇拜单抗200mg组和600mg组达到临床缓解的受试者比例分别是20.0%和14.0%，达到临床应答的受试者分别为54.0%和68.0%，达到症状缓解、内镜缓解或黏膜愈合的受试者比例均高于安慰剂组，总体安全性良好。 国内新药研发进展（部分） 05 国内新药研发领域政策法规动态 关于公开征求《放射性治疗药物申报上市临床风险管理计划技术指导原则（征求意见稿）》意见的通知 为进一步指导放射性治疗药物申报上市时的风险管理，我中心组织起草了《放射性治疗药物申报上市临床风险管理计划技术指导原则（征求意见稿）》。 我们诚挚地欢迎社会各界对征求意见稿提出宝贵意见和建议，并及时反馈给我们，以便后续完善。征求意见时限为自发布之日起1个月。 06 国内新药研发领域热点新闻 翰森制药「熬出头了」 2019年之前，翰森制药还是一家以仿制药为主的传统制药企业，仿制药业务收入和利润增速的放缓，让其下定决心转型创新药。 然而，创新转型并非一帆风顺。2022年，翰森制药创新药数量从2019年之前的1款增加到7款，创新药收入占比也首次超过了仿制药，达到了50.6%，但也就是在这一年，翰森制药营收和净利润首次出现负增长。 直到2024年中报业绩出炉，营收65.06亿元，同比增长44.21%，净利润27.26亿元，同比增长111.47%，创新药收入占比高达77.34%。一切质疑烟消云散，翰森制药进化到了势不可挡的阶段。更多资讯，请阅读原文 宜明昂科，下一代Biotech龙头浮出水面？ 随着双抗出海升温，研发管线以双抗为主的宜明昂科-B，股价自9月12日以来累计涨幅高达约100%。 资本市场的加持，加之双抗管线达成大额BD交易，下一代Biotech龙头正在浮出水面。 商业化近在咫尺 对于带“B”标签的Biotech，投资者最关心的问题就是：什么时候能实现扭亏为盈？ 随着越来越多Biotech凭借管线出海实现盈利，宜明昂科也紧跟这一趋势，达成了大额BD交易。更多资讯，请阅读原文 咨询、合作请联系作者 小D有话说 为方便读者阅读及保存，我们将周报原文整理成了PDF版本，如需获取全文，可点击最上方蓝字，在药渡Daily公众号后台回复“1024创新药周报”，即可下载。