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CStone Pharmaceuticals’ Gavreto Approved for First-Line RET Fusion-Positive NSCLC Treatment in China
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China-based CStone Pharmaceuticals (HKG: 2616) has announced that the National Medical Products Administration (NMPA) of China has granted approval for a supplemental new drug application (sNDA) for Gavreto (pralsetinib). This approval is for the first-line treatment of adults with locally advanced or metastatic RET fusion-positive non-small cell lung cancer (NSCLC).…
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CSPC Pharmaceutical’s Biosimilar Omalizumab Accepted for Review by China’s NMPA
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that the National Medical Products Administration (NMPA) has accepted a market filing for its biosimilar version of Novartis’ (NYSE: NVS) Xolair (omalizumab) for review. This development marks a significant step towards expanding treatment options for patients with allergic asthma and chronic…
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Henlius Biotech’s HLX13 Biosimilar Gets NMPA Approval for Liver Cancer Clinical Trial
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Shanghai Henlius Biotech, Inc (HKG: 2696) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its HLX13, a biosimilar of US major Bristol-Myers Squibb’s (BMS, NYSE: BMY) Yervoy (ipilimumab), for the treatment of liver cancer. HLX13: A CTLA-4 Monoclonal Antibody for Cancer TreatmentsHLX13 is a…
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Chia Tai Tianqing Launches First Batch of F-627 for Neutropenia Treatment in China
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China-based Chia Tai Tianqing has announced the first batch prescriptions in China for its efbemalenograstim alfa (F-627), an in-house developed long-acting recombinant human granulocyte colony stimulating factor (rhGCSF)-Fc fusion protein. The drug is indicated for the prevention and treatment of neutropenia during chemotherapy in cancer patients. F-627 received marketing approval…
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Jiangsu Kanion Pharmaceutical Gets FDA Approval for KYS202002A Clinical Study in Multiple Myeloma
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China-based Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced receiving the green light from the US Food and Drug Administration (FDA) to conduct a clinical study for its pipeline candidate KYS202002A, focusing on recurrent/refractory multiple myeloma (R/R MM). This follows the molecule’s approval for clinical trials in China in…
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Mega Lifesciences Secures Exclusive Rights for Bio-Thera’s Bevacizumab Biosimilar in Indonesia
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Thailand-based Mega Lifesciences (BKK: MEGA) has announced an in-licensing agreement with China-based Bio-Thera Solutions (SHA: 688177) for bevacizumab (BAT1706), a biosimilar version of Roche’s (SWX: ROG) Avastin (bevacizumab). According to the agreement, Mega Lifesciences obtains exclusive distribution and marketing rights to the product in Indonesia, while Bio-Thera will handle the…
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Jiangsu Hengrui’s Dalpiciclib Approved for Initial Therapy in HR+, HER2- Breast Cancer
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced receiving another indication approval for its drug dalpiciclib (SHR6390). The approval is for use as an initial therapy combined with an aromatase inhibitor for patients with hormone receptor (HR) positive, human epidermal growth factor…
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Fosun Kite’s Yescarta Gains NMPA Approval for Refractory Large B-Cell Lymphoma
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China-based Fosun Kite Biotechnology Co., Ltd, a joint venture between Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196; HKG: 2196) and Gilead (NASDAQ: GILD) subsidiary Kite Pharma, has announced that its product Yescarta (axicabtagene ciloleucel) has obtained marketing approval from the National Medical Products Administration (NMPA) for a new indication…
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Sinopharm Expands Partnership with Guizhou Government to Boost Health Industry
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China National Pharmaceutical Group Corporation (Sinopharm, HKG: 1099) has announced a strengthened partnership with the government of Guizhou province. This collaboration expands upon previous achievements in promoting cooperation in biomedicine, traditional Chinese medicine R&D, and the construction of grassroots public health systems. Comprehensive Cooperation in Pharmaceutical and HealthcareThe two parties…
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Coherent Biopharma and C-Ray Therapeutics Partner to Advance Peptide-Drug Conjugate Development
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China-based Coherent Biopharma and C-Ray Therapeutics have announced a strategic partnership to delve into the development of peptide-drug conjugates (PDCs), with a particular focus on bispecific-ligand drug conjugates (bi-XDCs). The collaboration aims to leverage the strengths of both companies to advance in this innovative field of drug development. Financial details…
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CANbridge Pharmaceuticals Reports Positive Phase Ib Results for Omoprubart in PNH Treatment
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China-based rare disease firm CANbridge Pharmaceuticals Inc., (HKG: 1228) has published the preliminary results of a Phase Ib clinical study for its pipeline drug candidate omoprubart (CAN106), a long-acting monoclonal antibody (mAb) targeting C5 of the complement system. The drug candidate is under development as a potential treatment for paroxysmal…
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Sino Medical Sciences Technology Secures FDA Thailand Approval for NC Rockstar Balloon Catheter
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China-based Sino Medical Sciences Technology Inc., (SHA: 688108) has announced that it has received market approval from the Food and Drug Administration of Thailand for its NC Rockstar noncompliant balloon catheter. This development marks a significant step for the company’s expansion into the Southeast Asian medical device market. Product Composition…
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Haisco Pharmaceutical’s HSK31679 Receives Clinical Trial Approval for NASH Treatment
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that its in-house developed Category 1 drug candidate, HSK31679, has obtained clinical trial approval for the treatment of non-alcoholic steatohepatitis (NASH). HSK31679: A Selective THR-β Agonist for Lipid MetabolismHSK31679 is a highly selective thyroid hormone β receptor (THR-β) agonist that…
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NMPA Approves XZenith Biopharm’s Anaprazole for Duodenal Ulcer Treatment
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The National Medical Product Administration (NMPA) has granted marketing approval for anaprazole, a proton pump inhibitor (PPI) developed by China-based XZenith Biopharm. This home-grown Category 1 drug is now approved for use in treating duodenal ulcers. Anaprazole’s Mechanism of Action and Clinical AdvantagesAnaprazole, a benzimidazole compound, functions by inhibiting gastric…
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Sichuan Kelun’s SKB264 Earns Breakthrough Therapy Designation for Breast Cancer Treatment
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The Center for Drug Evaluation (CDE) website has indicated that China-based Sichuan Kelun Pharmaceutical Co., Ltd’s (SHE: 002422) antibody-drug conjugate (ADC) SKB264, targeting trophoblast cell-surface antigen 2 (TROP2), has obtained breakthrough therapy designation (BTD) status. This designation is for use in locally advanced or metastatic hormone receptor positive and HER2…
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Shionogi’s Acquisition of Qpex Impacts Brii Biosciences’ Rights to Anti-infective Drugs
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Japan’s Shionogi & Co., Ltd (TYO: 4507) announced on June 26, 2023, its planned acquisition of US anti-infectives specialist Qpex Biopharma Inc., for USD 100 million upfront and an additional USD 40 million based on certain development and regulatory milestones. This deal has significant implications for China-based biotech Brii Biosciences…
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Innovent Biologics and RemeGen Partner on Clinical Study for PD-1 Inhibitor and ADC Drugs
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China-based Innovent Biologics Inc., (HKG: 1801) has entered into a clinical study and supply cooperation agreement with compatriot firm RemeGen (HKG: 9995). The collaboration will pair Innovent’s programmed death-1 (PD-1) inhibitor Tyvyt (sintilimab injection) with RemeGen’s antibody drug conjugate (ADC) drug candidates RC88 and RC108 in a clinical study. Clinical…
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Sino-Cuban JV Biotech Pharmaceutical Receives NMPA Approval for Nimotuzumab in Pancreatic Cancer
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Sino-Cuban joint venture (JV) Biotech Pharmaceutical Limited (BPL) announced last week that it has received an indication extension from China’s National Medical Products Administration (NMPA) for its biologic drug nimotuzumab. This new approval marks an expansion of the drug’s use beyond its original authorization in nasopharyngeal carcinoma (NPC) to now…
