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Hengrui Medicine Gains Approval for Phase Ib/II Study of SHR-A1811 and SHR-1701 in HER2-Positive Gastric Cancer
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced receiving approval to initiate a Phase Ib/II clinical study in China for its SHR-A1811 combined with SHR-1701 in patients with HER2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ). This approval marks a significant step forward in the development of…
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Zhejiang Pushkang Biotech Raises RMB 100M in Series C+ Financing
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China-based Zhejiang Pushkang Biotechnology Co., Ltd, a leading centrifugal microfluidic platform company, has reportedly raised over RMB 100 million (USD 13.7 million) in a Series C+ financing round. The round was led by Oct. Capital, with participation from Momentum Venture and Chang An Hui Tong, alongside returning investor Yinglian Health…
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Sinovac Partners with Colombia University to Boost Vaccine R&D
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China’s Sinovac (NASDAQ: SVA) has announced a partnership with Universidad de Antioquia of Colombia (UdeA) to collaborate on the construction of a vaccine research and development (R&D) center. The collaboration aims to enhance technical exchanges on vaccines and novel therapies, as well as to conduct basic research and translational studies…
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SeeNeuro Medical Raises RMB 100M in Series B Funding for Neural Regulation Devices
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Hangzhou-based SeeNeuro Medical, a developer of implantable neural regulation devices, has reportedly raised RMB 100 million (USD 13.7 million) in a Series B financing round. The funding was led by SDIC Unity Capital, with participation from BioTrack Capital, a returning investor. The proceeds will be used to support new product…
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MicuRx Pharmaceuticals Concludes US Phase I Study for MRX-8
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Shanghai-based antibacterial drug developer MicuRx Pharmaceuticals (SHA: 688373) has announced the conclusion of Phase I of its first-in-human study for MRX-8, a new drug targeting gram-negative drug-resistant bacteria, in the United States. The results demonstrated that at the expected clinical dose, MRX-8 exhibited an acceptable safety and pharmacokinetic profile in…
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Henlius Biotech’s Hanbeitai Approved for Hepatocellular Carcinoma
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Shanghai Henlius Biotech Inc. (HKG: 2696) has announced receiving a fourth indication approval from the National Medical Products Administration (NMPA) for its bevacizumab biosimilar, Hanbeitai. The drug is now approved for the treatment of hepatocellular carcinoma (HCC), expanding its therapeutic applications in China. Previous Approvals and Therapeutic IndicationsHanbeitai was first…
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Antengene’s Xpovio Receives Taiwan FDA Approval for Multiple Indications
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China-based biopharma Antengene Corp., Ltd (HKG: 6996) has announced receiving market approval from the Taiwan Food and Drug Administration (TFDA) for its drug Xpovio (selinexor) in three indications. The approvals cover the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) and relapsed or refractory diffuse large…
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AIM Vaccine Receives CDE Approval for Serum-Free Rabies Vaccine Trial
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced receiving clinical trial approval from the Center for Drug Evaluation (CDE) for its investigational lyophilized human rabies vaccine (serum-free Vero cells). This approval marks a significant step forward in the company’s efforts to develop and commercialize innovative rabies vaccines. Vero Cells…
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Rici Healthcare to Acquire Unicorn II Holdings for RMB 180M
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China-based Rici Healthcare Holdings Limited (HKG: 1526), also known as Rich Healthcare, is set to acquire 1,672,140 shares of Unicorn II Holdings Limited for RMB 180 million (USD 24.7 million). The acquisition aims to strengthen Rici Healthcare’s position in the rapidly growing private medical services sector in China. Market Growth…
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Roche Reports Q3 Sales Growth, Hit by COVID-19 Product Decline
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Swiss pharmaceutical giant Roche (SWX: ROG) released its Q3 2022 financial report last week, showing group sales up 2% year-on-year (YOY) at constant exchange rates (CER) during the 9-month period to CHF 47.0 billion (USD 46.8 billion). The growth rates for Q1, Q2, and Q3 were +11%, +0%, and -6%…
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Ambrx Biopharma Halts Development of HER2 ADC ARX788, Cuts Workforce
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US-based, China-owned biotech Ambrx Biopharma Inc. (NYSE: AMAM) has announced plans to end the development of its HER2-targeted antibody drug conjugate (ADC) pipeline candidate ARX788. The decision follows a strategic assessment of factors including cash runway, pipeline near-term value creation opportunities, and other considerations. As a result, the company also…
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Sinopharm’s Wuhan Institute Isolates Monkeypox Strains, Begins Vaccine Research
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China’s Wuhan Institute of Biological Products, a research affiliate of Sinopharm’s China National Biotech Group (CNBG), has announced that it has successfully isolated monkeypox strains from clinical samples. This development marks a significant step in the global effort to combat the infectious disease. Research has now begun on developing vaccines…
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CATUG Biotechnology Partners with Duoning to Advance mRNA Industrialization
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China-based CATUG Biotechnology (Suzhou) Co., Ltd has entered into a partnership with compatriot firm Shanghai Duoning Biotechnology Co., Ltd, with the goal of strengthening the development of its mRNA industrialization platform. The collaboration aims to enhance the production capabilities and regulatory compliance of mRNA vaccines and drugs. No financial details…
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Fujian Procurement Center Announces VBP for Cardiac and Laparoscopic Medical Consumables
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The Fujian drug and device joint procurement center has released two separate notifications regarding the inter-provincial alliance volume-based procurement (VBP) of medical consumables. The initiatives target cardiac intervention electrophysiology and endoscopic cutting stapler/suture products. The documents outline the specific procurement modes, selection rules, and other details. The time for enterprise…
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NMPA Releases 61st Batch of Reference Drugs for Generic Quality Consistency Evaluation
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The National Medical Products Administration (NMPA) has released the 61st batch of reference drugs for generic quality consistency evaluation (GQCE) work. This batch includes 57 new specifications and 18 specifications with modifications, highlighting the ongoing efforts to ensure the quality and consistency of generic drugs in China. Inclusion of Biogen’s…
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Betta Pharmaceuticals’ BPI-460372 Accepted for Clinical Trial Review by NMPA
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China’s Betta Pharmaceuticals (SHE: 300558) has announced that its clinical trial filing for the Category 1 drug candidate BPI-460372 has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication for the drug is advanced solid tumors, marking a significant step forward in the development of…
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Frontier Biotechnologies Secures Approval for HIV Therapy Alfusid
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Nanjing-based Frontier Biotechnologies Inc. has announced that its supplementary market filing for Alfusid (albuvirtide), China’s first homegrown innovative HIV therapy, has been approved. The approval allows the drug to be administered via intravenous bolus, significantly reducing the administration time. Alfusid: World’s First Long-Acting HIV DrugAlfusid is described as the world’s…
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Hengrui’s Camrelizumab and Akeso’s AK112 Set to Receive Breakthrough Designation in China
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The Center for Drug Evaluation (CDE) website indicates that China-based Jiangsu Hengrui Medicine Co., Ltd’s (SHA: 600276) new indication filing for its programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab, combined with the multi-kinase inhibitor famitinib, is set to receive Breakthrough Therapy Designation (BTD) status. The combination is intended as a…
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China Approves GSK’s Juluca for HIV-1 Infection
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The National Medical Products Administration (NMPA) has approved the market application for GlaxoSmithKline’s (GSK, NYSE: GSK) Juluca (dolutegravir/rilpivirine), a dual therapy for adult patients infected with human immunodeficiency virus type 1 (HIV-1). This approval marks a significant milestone, as Juluca is the first dual therapy approved by the FDA for…
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Hengrui Medicine Files for Dalpiciclib as Initial Therapy for Breast Cancer
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced a supplementary market filing for its CDK 4/6 inhibitor, dalpiciclib (SHR6390), as an initial therapy combined with an aromatase inhibitor for patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast…
