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Hengrui Pharmaceuticals Gets NMPA Approval for SHR-1819 Phase II Study
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that it has received the green light from the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for its investigational drug SHR-1819. This approval is a significant step forward in the development of SHR-1819, which is…
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Hengrui Pharmaceuticals Receives NMPA Approval for SHR-4375 Clinical Trial
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its therapeutic biologic product SHR-4375. This approval is a significant milestone in the development of SHR-4375, which is designed to treat advanced malignant solid tumors.…
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Ouro Medicines Launches with $120M Series A Financing for CM336 Development
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Ouro Medicines, the licensee of China-based Keymed Biosciences Inc.’s (HKG: 2162) CM336, has successfully launched with a USD 120 million Series A financing round. The California-headquartered biotech, founded by Monograph Capital in partnership with GSK plc (NYSE: GSK), saw the funding co-led by TPG Life Sciences Innovations, NEA, and Norwest…
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Menarini Group Expands Oncology Pipeline with Insilico Medicine License
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Italy’s Menarini Group, through its subsidiary Stemline Therapeutics Inc., has entered into a licensing deal with China-based AI drug discovery firm Insilico Medicine. The agreement grants Menarini global development and commercialization rights to a preclinical small molecule targeting oncology indications. This strategic move further expands Menarini’s oncology pipeline, leveraging Insilico’s…
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Zai Lab Secures Rights to Vertex’s Povetacicept in Key Asian Markets
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China-based biotech Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) has announced an exclusive collaboration and license agreement with US-headquartered Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX). Through this agreement, Zai Lab has obtained the development and commercialization rights to Vertex’s povetacicept (pove) in mainland China, Hong Kong SAR, Macau SAR, Taiwan region,…
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Light Horse Therapeutics Partners with Novartis in First-in-Class Drug Development
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US-based Light Horse Therapeutics Inc., a small molecule drug developer that recently emerged from the Inception Incubator with a USD 62 million Series A funding, has struck a strategic partnership with Swiss pharmaceutical giant Novartis (NYSE: NVS). The collaboration aims to identify and develop potentially first-in-class therapeutics using Light Horse’s…
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Samsung Bioepis and Teva Partner on Biosimilar EPYLLI for US Market
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South Korea’s Samsung Bioepis and Israel-based Teva Pharmaceutical (NYSE: TEVA) have entered into a license, development, and commercialization agreement focused on Samsung Bioepis’s EPYLLI, a biosimilar competing with AstraZeneca’s (AZ; NASDAQ: AZN) Soliris (eculizumab) on the US market. Under the partnership, Samsung Bio will be responsible for the development, regulatory…
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Sepax Technologies Debuts on STAR Market with Soaring IPO Prices
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Sino-US firm Sepax Technologies Co., Inc. has successfully completed its initial public offering (IPO) on the Shanghai Stock Exchange’s Sci-Tech Innovation Board (STAR). The opening price of RMB 28.15 per share marked a significant increase of 551% from the issue price of RMB 4.32. The final closing price settled at…
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Bayer Files for Finerenone Approval in US and China for Heart Failure-Fineline Info & Tech
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Bayer AG (ETR: BAYN) has announced market filings with the US Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for its drug finerenone. The German pharmaceutical giant is seeking approvals in both countries for the mineralocorticoid receptor (MR) antagonist…
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Pfizer’s Sasanlimab Shows Positive Results in Phase III CREST Study
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US-based Pfizer Inc. (NYSE: PFE) has reported positive topline results from its pivotal Phase III CREST study. The study evaluated sasanlimab, an investigational anti-PD-1 monoclonal antibody (mAb), in combination with Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).…
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NMPA Approves J&J’s FGFR Kinase Inhibitor Balversa for Urothelial Carcinoma
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China’s National Medical Products Administration (NMPA) has approved Johnson & Johnson’s (J&J; NYSE: JNJ) FGFR kinase inhibitor Balversa (erdafitinib) for the treatment of adult patients with unresectable locally advanced or metastatic urothelial carcinoma (UC). The drug is indicated for patients who carry susceptible FGFR3 gene mutations and have undergone at…
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Doma Biopharma Receives FDA Clearance for DM002 Phase I Study-Fineline Info & Tech
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China-based Doma Biopharmaceutical (Suzhou) Co., Ltd has announced that it has received clearance from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study. The study will assess the safety, tolerability, and preliminary anti-tumor activity of its Category 1 drug DM002 in multiple solid tumors. This…
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GSK’s Shingrix Prefilled Syringe Accepted for FDA Review
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UK-headquartered GlaxoSmithKline (GSK; NYSE: GSK) has announced that a market filing for a prefilled syringe presentation of its recombinant zoster vaccine Shingrix has been accepted for review by the US Food and Drug Administration (FDA). This development marks a significant step towards enhancing the convenience and efficiency of vaccine administration.…
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Shenzhen Oculgen Secures Over RMB 100 Million in Series A Funding
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Shenzhen Oculgen Biomedical Technology Co., Ltd. has successfully completed a Series A financing round, raising over RMB 100 million (USD 14.46 million). The round was led by LongRiver Jiangyuan Investment, with additional participation from Nanshan Zhanxin Investment, Junshi Venture Capital, Boyuan Capital, and Qingsong Capital. Existing investor Genesis Venture also…
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Fosun Pharmaceutical’s FCN-437c Accepted for NMPA Review for Breast Cancer Treatment
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Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196, SHA: 600196) has announced that another market approval filing for its FCN-437c has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the development of a new treatment option for patients with hormone receptor (HR)…
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Hengrui’s SHR4640 Accepted for NMPA Review for Gout and Hyperuricemia Treatment
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that a market filing for its SHR4640 as a long-term treatment for primary gout with hyperuricemia has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the development of a new treatment…
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Keymed Biosciences Licenses CM313 to Timberlyne Therapeutics for Global Development
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China-based Keymed Biosciences Inc. (HKG: 2162) has entered into a licensing agreement with US firm Timberlyne Therapeutics, Inc., granting the startup biopharma exclusive development, manufacturing, and commercialization rights to its CM313, a CD38-targeted monoclonal antibody (mAb). The agreement covers global rights, excluding mainland China, Hong Kong, Macau, and Taiwan. Financial…
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Biocytogen and SOTIO Biotech Partner on Colorectal Cancer ADC Candidate SOT109
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China-based Biocytogen (HKG: 2315) has announced an option and licensing agreement with SOTIO Biotech, allowing the Czech Republic firm to use its tumor-targeted fully human antibodies to develop SOT109, SOTIO’s new antibody drug conjugate (ADC) candidate. The ADC is intended for the treatment of colorectal cancer and other gastrointestinal (GI)…
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Novo Nordisk and Valo Health Expand Partnership to Develop Treatments for Obesity and Diabetes
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Partners Novo Nordisk (NYSE: NVO) and Valo Health have announced an expanded partnership, aiming to discover and develop novel treatments for obesity, type 2 diabetes, and cardiovascular disease. The collaboration leverages Valo’s extensive human dataset and computation powered by artificial intelligence (AI) to accelerate the development of innovative therapies. Initial…
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Immunochina Pharmaceuticals Raises Series E Funding for CAR-T Therapy IM19
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Beijing-based biotech Immunochina Pharmaceuticals has reportedly raised “hundreds of millions” of renminbi in a Series E financing round. The round was led by BTH Coordinated Development Industrial Investment Fund, with contributions from Taiping Medical and Health Industry Equity Investment Fund, Beijing Science and Technology Innovation Group, Beijing Sun-Novo Pharmaceutical Research…
