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Joincare Pharmaceutical’s JKN2403 Gains NMPA Approval for COPD Clinical Trials
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China-based Jo2006incare Pharmaceutical Group Industry Co., Ltd (SHA: 600380) is set to advance its Category 1 chemical drug, JKN2403, into clinical trials for the treatment of moderate to severe chronic obstructive pulmonary disease (COPD), following approval from the National Medical Products Administration (NMPA). JKN2403: A Novel COPD Treatment with Promising…
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Sino Biopharmaceutical Ltd. Files for Benmelstobart and Anlotinib Combination Therapy in ASPS Treatment
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China-based Sino Biopharmaceutical Ltd (HKG: 1177) is poised to make another indication approval filing with the National Medical Products Administration (NMPA) for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450) in combination with the multi-target kinase inhibitor anlotinib. The targeted indication for this combination therapy is advanced alveolar…
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HighTide Therapeutics and SSY Group Ltd Join Forces to Tackle Metabolic and Aging Diseases
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China-based HighTide Therapeutics Inc. (HKG: 2511) has announced a strategic collaboration framework agreement with compatriot firm SSY Group Ltd. (HKG: 2005). The collaboration aims to integrate HighTide’s unique strengths in the multi-system collaborative innovation of natural products with SSY’s extensive experience in activity screening, formulation development, achievement transformation, quality control,…
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AIM Vaccine Co., Ltd Receives NMPA Clearance for Innovative Cell-Based Influenza Vaccine
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AIM Vaccine Co., Ltd (HKG: 6660), a China-based biopharmaceutical company, has announced that it has received clearance from the National Medical Products Administration (NMPA) to conduct a clinical study for its suspension cultured quadrivalent MDCK cell influenza vaccine. This marks a significant step forward in the development of a novel…
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Henlius Biotech Expands Partnership with Palleon Pharmaceuticals for Autoimmune Disease Treatment
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Shanghai Henlius Biotech Inc. (HKG: 2696), a leading biotechnology company based in China, has announced an expansion of its alliance with Palleon Pharmaceuticals Inc. This partnership, originally established in June 2022, now includes the US firm in the development and commercialization of a combination therapy using Palleon’s E-602 and Henlius’…
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AIM Vaccine Co., Ltd Receives NMPA Approval for Second-Gen Tetanus Vaccine Clinical Trial
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its second-generation high-valent adsorbed tetanus vaccine. This development is a significant step forward in the company’s efforts to combat a disease that is both serious and…
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MSD’s Clesrovimab for Infant RSV Protection: FDA Accepts BLA for Review
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for clesrovimab (MK-1654), the company’s investigational prophylactic long-acting monoclonal antibody. This antibody is designed to protect infants from respiratory syncytial virus (RSV) disease during their first…
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Photys Therapeutics and Novo Nordisk Partner to Develop Proximity-Based Therapies for Cardiometabolic Diseases
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US-based Photys Therapeutics, Inc. has entered into an agreement with Denmark-based Novo Nordisk A/S (NYSE: NVO) to collaborate on the development of innovative proximity-based therapeutics for a cardiometabolic disease target. This multi-year partnership aims to leverage the complementary strengths of both companies to advance new treatment options in the field…
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Merck to Acquire HUB Organoids Holding B.V., Advancing Organoid Technology in Drug Development
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Merck (NYSE: MRK) has announced a definitive agreement with the intention to acquire HUB Organoids Holding B.V. (HUB), a company specializing in organoid technology. Organoids, which are cell culture models that functionally resemble organs, hold the potential to revolutionize drug development by accelerating processes, enhancing disease treatment understanding across diverse…
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BioAge Labs and Novartis Partner to Discover Aging-Related Therapeutic Targets
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US-based BioAge Labs, Inc. has announced a strategic research partnership with Swiss pharmaceutical giant Novartis (NYSE: NVS). This multi-year collaboration aims to identify and validate novel therapeutic drug targets by delving into the biological mechanisms that underpin aging-related diseases and the beneficial effects of physical exercise. The partnership is designed…
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DaAn Gene Co., Ltd Receives NMPA Approval for Genetic Deafness Gene Detection Kit
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China-based DaAn Gene Co., Ltd, (SHE: 002030) affiliated with Sun Yat-sen University, has announced that it has received a Category III medical device license from the National Medical Products Administration (NMPA) for its genetic deafness gene detection kit, which employs PCR flow cytometry fluorescence hybridization methodology. Advanced Technology for Genetic…
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MediLink Therapeutics’ YL201 Receives FDA Orphan Drug Designation for Small-Cell Lung Cancer
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Suzhou-based biotech company MediLink Therapeutics (Suzhou) Co., Ltd has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for its antibody drug conjugate (ADC) YL201 for the treatment of small-cell lung cancer (SCLC). This designation highlights the potential impact of YL201 in addressing a…
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BMS Regains Exclusive Rights to ABZ-706 in Greater China
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Bristol-Myers Squibb (BMS; NYSE: BMY) has reached an agreement with China-based Ablaze Pharmaceuticals to regain exclusive development and commercialization rights for ABZ-706 in Greater China, which includes mainland China, Hong Kong, Macau, and Taiwan. ABZ-706 is a targeted therapy for liver cancer that focuses on the GPC3 biomarker. Background on…
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Everest Medicines’ Nefecon Receives First Prescription for IgAN Treatment in Adults
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China-based Everest Medicines (HKG: 1952) has announced that its targeted-release budesonide, Nefecon, has been prescribed for the first time to treat primary immunoglobulin A nephropathy (IgAN) in adults who are at risk of disease progression. This development signifies a significant step forward in the management of IgAN, a condition that…
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FDA Approves Xcovery Holdings’ Ensartinib for Untreated ALK-Positive NSCLC Patients
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On December 18, 2024, the Food and Drug Administration (FDA) granted approval for Betta Pharmaceutical (SHE: 300558) and its controlling subsidiary Xcovery Holdings, Inc.’s ensartinib (Ensacove), a treatment for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received…
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INT Medical Instruments to Acquire Controlling Stake in Weiqiang Medical Technology for RMB 230 Million
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Shanghai INT Medical Instruments Co., Ltd. (HKG: 1501) has announced its intention to acquire at least a 51% stake in its Chinese counterpart, Hangzhou Weiqiang Medical Technology Co.,Ltd. The acquisition will see INT Med make an initial upfront payment of RMB 30 million (USD 4.11 million), along with a substantial…
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Janssen-Cilag Submits for IMBRUVICA Indication Extension in Untreated Mantle Cell Lymphoma
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Janssen-Cilag International NV has announced the submission seeking approval for an indication extension of IMBRUVICA (ibrutinib) in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP). The extended indication is for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are eligible for autologous stem cell…
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iFlytek’s Subsidiary Xunfei Healthcare Technologies Lists on HKEX, Raises Over HKD 580 Million
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Xunfei Healthcare Technology Co., Ltd, a subsidiary of China-based information technology company iFlytek Co., Ltd (SHE: 002230), has officially launched its initial public offering (IPO) on the Hong Kong Stock Exchange. The company issued 7,035,550 shares at a price of HKD 82.8 per share, securing over HKD 580 million (USD…
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Chengdu Kanghua Biological Receives NMPA Approval for Recombinant Norovirus Vaccine
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Chengdu Kanghua Biological Products Co., Ltd, (SHE: 300841), a leading biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its recombinant hexavalent norovirus vaccine (Pichia pastoris). The vaccine is designed to prevent acute gastroenteritis caused by genotype…
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Sinocare Inc’s TRUE VIE CGMS Advances to 510(k) Substantive Review Stage at FDA
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Sinocare Inc (SHE: 300298), a China-based medical technology company, has announced that its continuous glucose monitoring system (CGMS), TRUE VIE CGMS, has entered the 510(k) substantive review stage at the US Food and Drug Administration (FDA). This milestone follows the successful passage of the initial acceptance review for the FDA…
