Heparin Calcium

SHANGHAI, China I January 20, 2025 I Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, and its wholly-owned subsidiary, TopAlliance Biosciences Inc. (TopAlliance Biosciences), announced a distribution and marketing partnership with LEO Pharma for toripalimab in Europe. This collaboration aims to promote the accessibility of toripalimab in Europe, offering high-quality, innovative treatments to patients across up to 32 European countries. Toripalimab, independently developed by Junshi Biosciences, is a monoclonal antibody targeting PD-1 for the treatment of multiple malignant tumors. To date, toripalimab has been approved for marketing in over 35 countries and regions around the world. In 2024, toripalimab received approvals from both the European Commission (EC) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the following indications: 1) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma (NPC); 2) in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). Toripalimab is the first and only drug in Europe for the treatment of NPC, and the only first-line treatment for advanced or metastatic ESCC, regardless of tumor PD-L1 expression status. Under the agreement, LEO Pharma will be responsible for toripalimab’s distribution, promotion, sales, etc., in up to 32 countries, including all member states of the European Union (EU) and the European Economic Area (EEA), as well as Switzerland and the United Kingdom. TopAlliance Biosciences Europe will remain the Marketing Authorization Holder (MAH) for toripalimab in Europe, retaining responsibility for product development, manufacturing, registration, pharmacovigilance, quality management, etc. LEO Pharma will make payments, including an upfront payment, milestone payments if LEO Pharma wishes to pursue any subsequently approved indications, and a revenue share of a double-digit percentage on the net sales of toripalimab throughout the collaboration territory. Dr. Sheng YAO, Senior Vice President of Junshi Biosciences and CEO of TopAlliance Biosciences , said, “The partnership with LEO Pharma has established a significant milestone for Junshi Biosciences in the European market and is closely aligned with the company’s global expansion strategy. Europe has been identified as a pivotal strategic region for the corporate business growth. As the Marketing Authorization Holder (MAH) of the product in Europe, the company has already established a local operational center and is actively collaborating with local health authorities to prepare for the successful commercial launch of toripalimab in Europe. As a century-old multinational pharmaceutical company headquartered in Europe, LEO Pharma has established a mature distribution network and rich marketing expertise in the local markets. By leveraging both parties’ strengths in R&D, manufacturing, and commercialization, we believe toripalimab will be efficiently integrated into the Europe markets benefitting local patients-in-need. Moving forward, we will continue to implement our ‘In China, For Global’ strategy and work with partners to provide high-quality, innovative therapies from China to patients worldwide.” Jean Monin, Executive Vice President of Thrombosis Business Unit, LEO Pharma , commented, “We are excited to partner with Junshi Biosciences, supplementing LEO Pharma’s Thrombosis business, which already serves patients with cancer-associated thrombosis. The distribution and marketing partnership for LOQTORZI® brings an important new treatment option to areas of high unmet medical need and focuses on a specialty hospital product that complement our existing heparin-based anti-coagulation treatments for cancer-associated thrombosis and other specialty patients. Leveraging our commercial platform, LOQTORZI® will create valuable synergies and drive continued growth.” About Toripalimab Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and to induce PD-1 receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells. More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Europe, and Southeast Asia. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin. In the Chinese mainland, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). Currently, there are ten approved indications for toripalimab in the Chinese mainland: The ten indications have been included in the National Reimbursement Drug List (NRDL) (2024 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma, perioperative treatment of NSCLC, treatment of RCC and treatment of TNBC. In October 2024, toripalimab for the treatment of recurrent or metastatic NPC was approved in Hong Kong SAR, China. Internationally, toripalimab has been approved for marketing in the United States, the European Union, India, the UK, Jordan, Australia and other countries and regions. In addition, toripalimab BLAs are under reviews in many countries around the globe, including the Singapore Health Sciences Authority (HSA). About LEO Pharma LEO Pharma is a global company dedicated to advancing the standard of care through innovation for the benefit of people with skin conditions. LEO Pharma also provides anti-coagulant therapy for cancer patients and other specialty patients. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. LEO Pharma offers a broad portfolio of treatments, serving 100 million patients annually. Headquartered in Denmark, LEO Pharma has a global team of 4,000 people. In 2023, the company generated net sales of $1.6 billion. For more information, please visit: https://www.leo-pharma.com. About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Five of the company’s products have received approvals in China and international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 35 countries and regions including China, the US, and Europe. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19. With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences is “In China, For Global.” At present, the company boasts approximately 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit: http://www.junshipharma.com. SOURCE: Junshi Biosciences

Submission of a Prior Approval Supplement for a reduction in the number of patients in the NEPHRO CRRT study is expected within the coming week The FDA agreed to two additional protocol changes expected to accelerate enrollment in the NEPHRO CRRT study SAN MATEO, Calif., Jan. 14, 2025 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), ("Talphera"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that following a meeting with the U.S. Food and Drug Administration (FDA), the agency has agreed to review a Prior Approval Supplement (PAS) requesting a reduction in the number of patients in the NEPHRO CRRT clinical study. A PAS is reviewed by the FDA within 30 days, and its approval by the agency is required before formally amending the study protocol. During this same meeting, the agency agreed to two other changes to broaden the clinical study inclusion criteria which would allow the Company to enroll patients already on continuous renal replacement therapy (CRRT) beyond 48 hours as well as heparin-tolerant patients at certain institutions. These changes are being made through a five-day protocol amendment notice to the FDA with no additional FDA review required. "We continue to evaluate and focus on opportunities to support completion of the NEPHRO CRRT study by the end of the year. In addition to new clinical sites, our continuous improvement efforts in study execution were strengthened following our positive face-to-face meeting with the FDA where the agency agreed we should submit a PAS to reduce the number of patients in the NEPHRO CRRT study. We plan to submit the PAS in the coming week which requires a review period of up to 30 days," stated Shakil Aslam, MD, Talphera's Chief Medical Officer. "Our breakthrough designation status and close collaboration with the FDA continue to support our confidence in the importance of nafamostat as an alternative anticoagulant for patients on CRRT," continued Dr. Aslam. About Talphera, Inc. Talphera, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. Talphera's lead product candidate, Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption (IDE) as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA). This release is intended for investors only. For additional information about Talphera, please visit www.talphera.com. About Niyad and nafamostat Nafamostat is a broad spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities. Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation Status from the FDA. Talphera's registrational study of Niyad™ is named the NEPHRO CRRT (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) study. An ICD-10 procedural code, XY0YX37, has been issued for the extracorporeal introduction of nafamostat. The ICD-10 code is a specific/billable code that can be used to indicate a procedure. LTX-608 is a proprietary nafamostat formulation for direct IV infusion that may be investigated and developed for the treatment of acute respiratory distress syndrome (ARDS), disseminated intravascular coagulation (DIC), acute pancreatitis or as an anti-viral treatment, amongst other potential targets. About the NEPHRO CRRT Study The NEPHRO Study, which has received central IRB approval, is designed as a prospective, double-blinded trial to be conducted at up to 14 U.S. hospital intensive care units. The study will enroll and evaluate 166 adult patients undergoing renal replacement therapy, who cannot tolerate heparin or are at risk for bleeding. The primary endpoint of the study is mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours. Key secondary endpoints include filter lifespan, number of filter changes over 72 hours, number of transfusions over 72 hours and dialysis efficacy (based on urea concentration) over the first 24 hours. Forward-looking statements This press release contains forward-looking statements based upon Talphera's current expectations and assumptions. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believe," "expect," "anticipate," "may," "if," "intends," "plans," "potential," "projected," "will," or the negative of these words or other comparable terminology, and include: Talphera's expectation that the NEPHRO study enrollment rates will accelerate due to the protocol changes, and will support the study completion by the end of 2025, and that the PAS will be submitted in the coming week. Talphera's discussion of its strategy, plans and intentions also include forward-looking statements, which are predictions, projections and other statements about future events that are based on current expectations and assumptions. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including: (i) risks relating to Talphera's product development activities, including that clinical studies may not be fully enrolled or completed and/or confirm any safety, efficacy or other potential developmental product characteristics described or assumed in this press release; (ii) Talphera's developmental product candidates may not be beneficial to patients or healthcare providers or be successfully commercialized; (iii) risks relating to Talphera's ability to obtain regulatory approvals for its developmental product candidates; (iv) risks related to the ability of Talphera and its business partners to implement development plans, commercial launch plans, forecasts and other business expectations; and (v) risks related to Talphera's liquidity and its ability to maintain capital resources sufficient to conduct its clinical studies. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described under the caption "Risk Factors" and elsewhere in Talphera's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in Talphera's most recent annual, quarterly or current report as filed or furnished with the SEC. Talphera's SEC reports are available at www.talphera.com under the "Investors" tab. Except to the extent required by law, Talphera undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect new information, events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events. View original content to download multimedia:https://www.prnewswire.com/news-releases/talphera-announces-agreement-with-the-fda-for-prior-approval-supplement-review-to-reduce-the-number-of-patients-in-the-nephro-crrt-study-302349947.html SOURCE Talphera, Inc. Investor Contacts: Talphera, Raffi Asadorian, CFO, 650-216-3500, investors@talphera.com; LifeSci Advisors, Kevin Gardner, 617-283-2856, kgardner@lifesciadvisors.com; Chris Calabrese, 917-680-5608, ccalabrese@lifesciadvisors.com