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The Center for Drug Evaluation (CDE) website indicates that a market approval filing from Legend Biotech Corporation (NASDAQ: LEGN) for its BCMA-directed chimeric antigen receptor (CAR) T cell therapy Carvykti (ciltacabtagene autoleucel) has been accepted for review. This makes Carvykti the third BCMA CAR-T therapy to be filed for marketing…
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UK-based biotech F-star Therapeutics (NASDAQ: FSTX) released an SEC filing indicating that the proposed acquisition by China’s Sino Biopharmaceutical (HKG: 1177) faces further delays. The notice indicates that on December 28, 2022, the US Committee on Foreign Investment to the US (CFIUS) issued an interim order warning the companies that…
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its pipeline drug candidate ALMB-0168 in osteoarthritis. ALMB-0168, a connexin 43-targeted monoclonal antibody developed in-house by subsidiary AlaMab Therapeutics Inc., is under development to treat acute…
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China-based biopharma RemeGen Ltd (HKG: 9995) has announced receiving approval from the US FDA to initiate a Phase I clinical study for its antibody drug conjugate (ADC) RC108 in c-Met positive advanced solid tumors. This marks a significant step forward in the global development of RC108, building on its existing…
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced receiving clearance from the National Medical Products Administration (NMPA) to conduct a clinical study for its SIM0348, a bispecific antibody (BsAb) targeting TIGIT and PVRIG in advanced malignant solid tumors. Mechanism of Action and DesignSIM0348 is designed to block the interaction between…
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Skynor Medical, a Shanghai-based manufacturer of nerve and peripheral blood vessel implantation and interventional devices, has reportedly raised RMB 100 million (USD 14.37 million) in a new financing round. Investors include Zhangjiang Hi-Tech Park Development, Pudong Capital, Zhangjiang Haoheng Innovative Equity Investment, and Suxin Venture Capital. The proceeds will be…
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China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has announced the completion of a financing round at RMB 1.5 billion (USD 215.53 million) for its subsidiary Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Kelun maintains majority control of the subsidiary with a 59.75% stake, increased from 55.41%. Merck, Sharp & Dohme (MSD;…
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China-based Everest Medicines (HKG: 1952) has announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has recommended Priority Review status for the New Drug Application (NDA) of Nefecon (targeted-release formulation-budesonide) for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk…
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China-based BrightGene Bio-Medical Technology Co., Ltd (SHA: 688166) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its BGM0504, a dual agonist targeting GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulin-stimulating polypeptide). The targeted indications for BGM0504 are weight loss and type…
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China-based Anhui Anke Biotechnology (Group) Co., Ltd (SHE: 300009) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its recombinant human growth hormone Fc fusion protein injection AK2017. The drug will be assessed for treating children with growth deficiencies due to endogenous…
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UK-based pharmaceutical major AstraZeneca (NASDAQ: AZN) has announced receiving market approval from the National Medical Products Administration (NMPA) for its Nexium (esomeprazole) to treat gastroesophageal reflux disease (GERD) in adolescents. This marks the proton pump inhibitor’s (PPI) first approval for a pediatric indication in China. Incidence and Treatment of GERD…
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China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced that its subsidiary Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd (CTTQ) has entered into a preliminary five-year licensing agreement with Japan-based Shionogi & Co., Ltd. Under the agreement, CTTQ will take exclusive market promotion rights to Shionogi’s oral COVID-19 therapy ensitrelvir in…
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Shenzhen-based heart failure mechanical circulatory support solutions provider, Shenzhen Core Medical Technology Co., Ltd, has reportedly raised “hundreds of millions” of renminbi in a Series C financing round. The round was led by investors including Yuanhenglizhen Management, Cornerstone Capital, Salubris Pharma, Nanshan SEI Investment, Beihang Investment, New Alliance Capital, and…
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China-based Sinovac Biotech Ltd (NASDAQ: SVA) has released its financial report for the first half of 2022, ending on June 30, 2022. The firm reported revenues of USD 1.2 billion, a significant drop from the USD 11.0 billion recorded in the same period a year earlier. Net income attributable to…
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The results of a Phase III clinical study for China-based Junshi Biosciences’ (HKG: 1877, SHA: 688180) oral nucleoside analog drug JT001 (VV116) have been published in the New England Journal of Medicine. The study compared VV116 with Pfizer’s Paxlovid (nirmatrelvir + ritonavir) as an early treatment for mild to moderate…
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China’s Hainan Shuangcheng Pharmaceutical Co., Ltd (SHE: 002693) has announced a Paragraph IV patent declaration in relation to the Abbreviated New Drug Application (ANDA) for its Paclitaxel, albumin-bound. This declaration indicates that Shuangcheng believes its drug does not infringe on the rights of Bristol-Myers Squibb’s (BMS, NYSE: BMY) originator drug…
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that its clinical study for the oral small molecule COVID-19 therapy GS221, a 3CLpro inhibitor, has delivered a good safety and tolerability profile. The study, approved in late September, observed no serious adverse events or adverse events leading to discontinuation. Efficacy…
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced a new initiative allowing mainland China consumers to register online for vaccinations using BioNTech’s (NASDAQ: BNTX) (DE: 22Uay) mRNA COVID-19 vaccine in Hong Kong. Interested individuals are required to arrange their own travel to Hong Kong once their…
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China-based chimeric antigen receptor T-cell (CAR-T) specialist Immunotech Biopharm Ltd (HKG: 6978) has announced that an Investigational New Drug (IND) filing for its CAR-T-19-D2 (CAR-T-19-DNR or RC19D2) has been accepted for review by the National Medical Products Administration (NMPA). The intended indication is recurrent and refractory diffuse large B-cell lymphoma…
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China-based Acotec Scientific Holdings Ltd (HKG: 6669) has announced receiving market approvals from the National Medical Products Administration (NMPA) for its products YAN and P-Conic balloon. These approvals mark significant milestones in the company’s product development and market expansion efforts. Product Details and ApplicationsYAN is a product designed to expand…