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Simcere Receives NMPA Clearance for SIM0348 Clinical Study
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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 Raises RMB 100 Million in Financing Round for Market Expansion
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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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Sichuan Kelun Completes RMB 1.5 Billion Financing Round for Kelun-Biotech
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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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Everest Medicines’ Nefecon Receives Priority Review Recommendation from CDE
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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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BrightGene Receives NMPA Approval for BGM0504 Clinical Trial
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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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AstraZeneca’s Nexium Approved by NMPA for Adolescent GERD Treatment
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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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Sino Biopharmaceutical Secures Rights to Shionogi’s COVID-19 Therapy Ensitrelvir
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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 Core Medical Raises ‘Hundreds of Millions’ in Series C Financing
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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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Sinovac Reports H1 2022 Financials Amid COVID-19 Vaccine Demand Decline
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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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Junshi Biosciences’ JT001 (VV116) Shows Non-Inferiority to Paxlovid in COVID-19 Trial
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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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Hainan Shuangcheng Files Paragraph IV Patent Declaration for Paclitaxel, Albumin-Bound
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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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Grand Pharma’s COVID-19 Therapy GS221 Shows Promising Safety Profile
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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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Fosun Pharma Launches Online Registration for BioNTech COVID-19 Vaccine in Hong Kong
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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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Immunotech Biopharm’s CAR-T-19-D2 IND Filing Accepted by NMPA
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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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Acotec Scientific Holdings Receives NMPA Approvals for YAN and P-Conic Balloon
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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…
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CanSino Biologics Updates Data from COVID-19 Vaccine Clinical Studies
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China-based CanSino Biologics (HKG: 6185) has provided data updates from three clinical studies for its adenovirus type-5 vector-based COVID-19 vaccines. The studies assess the safety and immunogenicity of CanSino’s vaccines in various age groups and vaccination scenarios. Study 1: Bivalent Inhaled Vaccine for AdultsThe first study focused on CanSino’s bivalent…
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Fortune Care Raises Over RMB 100 Million in Series C+ Financing Round
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China-based household healthcare and nursing brand Fortune Care reportedly raised over RMB 100 million (USD 14.33 million) in a Series C+ financing round. The round was solely led by a central government-owned enterprise. The proceeds will be used for commercial service and digital operation system construction, as well as nationwide…
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Guangzhou Mygene Raises ‘Hundreds of Millions’ in Series C Financing Led by Efund Capital
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China-based molecular diagnostic product developer Guangzhou Mygene Medical Technology Co., Ltd reportedly raised “hundreds of millions” of renminbi in a Series C financing round led by Efund Capital. Other investors included Anggu Fuge Investment, Juyo Capital, Benchi Capital, and Hongtu Runda Capital. The proceeds will be used for research and…
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WuXi Biologics Receives First GMP Certificate from Ireland HPRA
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China-based Contract Research, Development, and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) has announced receiving its first GMP certificate from the Ireland Health Products Regulatory Authority (HPRA) for clinical-and commercial-stage product release testing in Dundalk, Ireland. This marks the first Manufacturer’s/Importation Authorization (MIA) and Investigational Medicinal Product (IMP) license for…
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SciClone Pharmaceuticals’ Vaborem IND Filing Accepted by NMPA
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SciClone Pharmaceuticals Inc (HKG: 6600) has announced that an Investigational New Drug (IND) filing for its Vaborem (meropenem vaborbactam), a new antibacterial drug, has been accepted for review by the National Medical Products Administration (NMPA). The IND application covers a Phase III clinical study to evaluate the efficacy and safety…
