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AstraZeneca’s Dapagliflozin and Metformin Combo Approved by China’s NMPA for Type 2 Diabetes
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UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its fixed dose combination of dapagliflozin and metformin, a treatment for type 2 diabetes. This once-daily compound is now the only sustained-release formulation in China…
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LianBio’s Mavacamten Receives Priority Review Status from China’s CDE for oHCM Treatment
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The Center for Drug Evaluation (CDE) has indicated on its website that China-based biotech firm LianBio (Nasdaq: LIAN) has been awarded priority review status for its drug mavacamten. This status is for the treatment of adult patients with symptomatic New York Heart Association (NYHA) heart function II-III obstructive hypertrophic cardiomyopathy…
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CSPC Pharmaceutical Group Gets NMPA Approval for JMT203 Cancer Cachexia Clinical Study
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its in-house developed Category 1 antibody, JMT203. This marks a significant step forward in the development of this novel treatment for cancer cachexia.…
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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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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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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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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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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…
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Sarepta Therapeutics’ Elevidys Receives FDA Accelerated Approval for Duchenne Muscular Dystrophy
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US-based Sarepta Therapeutics, Inc. (NASDAQ: SRPT) has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Elevidys (delandistrogene moxeparvovec-rokl), an adeno-associated virus-based gene therapy co-developed by Roche. This treatment is designed for ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD)…
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S-Evans Biosciences Receives NMPA Tacit Approval for Stem Cell Therapy in ARDS
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S-Evans Biosciences, a stem cell specialist based in Hangzhou, has obtained tacit clinical trial approval from the National Medical Products Administration (NMPA) for its “human umbilical cord mesenchymal stem cell injection” in the treatment of moderate to severe acute respiratory distress syndrome (ARDS). Product Development and ARDS OverviewThe in-house developed…
