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Bio-Thera Solutions Receives NMPA Approval for BAT8008 Clinical Trial in Solid Tumors
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Bio-Thera Solutions (SHA: 688177), a Guangzhou-based biotech firm, has received approval from the National Medical Products Administration (NMPA) to conduct a clinical trial for BAT8008, its antibody-drug conjugate (ADC) targeting solid tumors. This marks the fourth product from Bio-Thera’s pipeline to advance into clinical trials. Drug ProfileBAT8008 combines a recombinant…
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BeiGene’s Tislelizumab Receives 11th NMPA Filing for First-Line Esophageal Cancer
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BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) announced that the National Medical Products Administration (NMPA) has accepted a supplementary Biologic License Application (sBLA) for its PD-1 inhibitor tislelizumab, seeking approval for first-line treatment of unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). This marks the 11th market…
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Innovent Biologics Doses First Patient in Australia Trial for PD-1/IL-2 Bispecific Antibody IBI363
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China-based Innovent Biologics, Inc. (HKG: 1801) announced that the first patient has been dosed in a Phase I clinical trial of IBI363, an in-house developed PD-1/IL-2 bispecific antibody (BsAb) fusion protein, in Australia. The trial will evaluate the safety, tolerability, and preliminary efficacy of IBI363 in patients with advanced solid…
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Lee’s Pharma Expands Global Rights to Windtree’s KL4 Surfactant Products
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has expanded its licensing agreement with US-based Windtree Therapeutics, Inc. (NASDAQ: WINT), securing global exclusive rights to develop, manufacture, and commercialize KL4 surfactant products, including Surfaxin, Surfaxin LS, and Aerosurf. The revised deal, effective August 9, 2022, builds on the initial agreement signed…
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Genetron Holdings Receives Buyout Offer from CEO Wang Sizhen at USD 1.36 per ADS
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Beijing-based precision oncology firm Genetron Holdings Ltd announced receipt of a buyout and take-private offer from CEO, co-founder, and chairman Wang Sizhen. The proposal values the company at USD 0.272 per ordinary share, or USD 1.36 per American depositary share (ADS). Company BackgroundGenetron specializes in molecular profiling tests, early cancer…
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Supreme People’s Court Rules Against Chugai in China’s First Patent Linkage Case
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China’s Supreme People’s Court has delivered its verdict in the nation’s first patent linkage dispute, ruling against Japan’s Chugai Pharmaceutical Co., Ltd and in favor of generic drugmaker Wenzhou Haihe Pharmaceutical Co., Ltd. The case, involving osteoporosis drug eldecalcitol, marks a milestone under China’s Drug Patent Early Dispute Resolution Mechanism,…
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Ascletis Pharma’s H1 2022 Revenue Rises 4.8% on R&D and Product Sales Growth
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Ascletis Pharma Inc. (HKG: 1672) reported RMB 38.2 million (USD 5.96 million) in revenue for the six months ending June 30, 2022, a 4.8% year-on-year (YOY) increase. The firm’s research and development (R&D) expenditure surged 60.5% YOY to RMB 118.8 million (USD 18.54 million), while cash reserves stood at RMB…
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Viatris Pharmaceuticals’ HIV/AIDS Drug Prioritized for CDE Review
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The Center for Drug Evaluation (CDE) has indicated that Viatris Pharmaceuticals Co., Ltd’s efavirenz/lamivudine/tenofovir is set for prioritized review. The drug is used to treat HIV/AIDS, combining three active ingredients to target viral replication. Drug Profile Global ApprovalsThe compound is marketed abroad under two single-dose regimes:
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Hansoh Pharma Licenses GHDDI’s GDI-4405 for Global Development in COVID-19
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced a licensing agreement with the Global Health Drug Discovery Institute (GHDDI) to develop the COVID-19 therapy GDI-4405. Hansoh will gain exclusive global rights to the drug’s clinical development, manufacturing, and commercialization. Agreement DetailsHansoh will pay GHDDI an upfront fee of RMB…
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Anhui Anke’s HK010 Bispecific Antibody Receives NMPA Review for Cancer Trials
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Anhui Anke Biotechnology (Group) Co., Ltd (SHE: 300009) announced that the National Medical Products Administration (NMPA) has accepted a clinical trial filing for HK010, a bispecific antibody (BsAb) targeting PD-L1 and 4-1BB, for the treatment of advanced malignant tumors. Drug ProfileHK010 is designed to block the PD-L1/PD-1 pathway while conditionally…
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China-Based Firms Form Partnership to Advance Cell and Gene Therapy Ecosystem
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Six China-based companies—Porton Advanced Solutions Ltd, Shanghai Sequanta Biological Technology Co., Ltd, QuaCell Biotechnology Co., Ltd, EurekaBio Technology Co., Ltd, SAFE Pharmaceutical Technology Co., Ltd, and SanQ (Beijing) Biotechnology Co., Ltd—have formed a strategic partnership in the cell and gene therapy (CGT) sector. The collaboration aims to create a comprehensive…
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BIOPSEE Series A+ Financing Confocal Microendoscope
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BIOPSEE, a Hubei-based microendoscope specialist, has raised tens of millions of renminbi in a Series A+ financing round led by Ezhou Changda Investment, Suzhou High-Tech Venture Capital, Suzhou Kejicheng Venture Capital, and SND Group. The funds will support research and development, scaled manufacturing, and clinical applications of confocal microendoscope products.…
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CSPC Pharmaceutical’s DBPR108 Hits Endpoints in Type 2 Diabetes Trials
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that its Category 1 drug DBPR108 has achieved endpoints in two Phase III clinical studies for type 2 diabetes. The oral dipeptidyl peptidase-IV (DPP-4) inhibitor demonstrated efficacy both as a monotherapy and in combination with other drugs, recruiting over 1,000 patients in…
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Shanghai Pharmaceuticals Gets NMPA Approval for B013 in Triple-Negative Breast Cancer
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Shanghai Pharmaceuticals (HKG: 2607, SHA: 601607) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II/III clinical trial of its Category 1 biologic B013, combined with albumin paclitaxel, for first-line treatment of locally advanced or metastatic triple-negative breast cancer (TNBC). Drug ProfileB013, a potential first-in-class…
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Scitop Bio-tech’s KEX02 Live Bacteria Therapy Gets FDA IND Approval for NSCLC
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Beijing Scitop Bio-tech Co., Ltd (SHE: 300858) announced that the US Food and Drug Administration (FDA) has granted Investigational New Drug (IND) approval for its live bacteria therapeutic candidate KEX02, to be tested in combination with a PD-1 inhibitor for the treatment of non-small cell lung cancer (NSCLC). About KEX02KEX02…
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Sanyou Biopharmaceuticals and KangaBio Ink Licensing Deal for Antibody Drug Candidate
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Shanghai-based Sanyou Biopharmaceuticals Co., Ltd and KangaBio have entered into a licensing agreement, granting Kanga exclusive rights to research, develop, manufacture, and commercialize Sanyou’s in-house antibody drug candidate. Financial details of the deal were not disclosed. Agreement DetailsThe agreement builds on a previous licensing term list for two of Sanyou’s…
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InnoCare Pharma’s 2022 Interim Report Shows Strong Revenue Growth Driven by Orelabrutinib Sales
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China-based InnoCare Pharma (HKG: 9969) announced its 2022 interim financial results, reporting total revenues of RMB 246 million (USD 36 million), a 142% year-on-year (YOY) increase. The growth was primarily driven by a 115% sales volume increase of its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib, which was added to the…
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Porton Biologics Completes RMB 520M Series B to Expand Gene and Cell Therapy CDMO Platform
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Suzhou Porton Biologics Ltd, a China-based contract development and manufacturing organization (CDMO), announced the completion of a Series B financing round totaling RMB 520 million (USD 76.1 million). The round was led by China Merchants Health Industry Holding Co., Ltd, with participation from CMS Capital, China Merchants Security, Fosun Health…
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Nuance Pharma Gets NMPA Green Light for Ensifentrine COPD Trials in China
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China-based Nuance Pharma has secured approval from the National Medical Products Administration (NMPA) to conduct both Phase I and Phase III clinical trials for ensifentrine, a dual inhibitor of phosphodiesterase 3 and 4 (PDE3 and PDE4), as a maintenance treatment for chronic obstructive pulmonary disease (COPD). Partnership and DevelopmentThe drug…
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Lundbeck’s Vyepti Fails to Accelerate China Launch via SUNLIGHT Trial
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Lundbeck’s attempt to fast-track migraine drug Vyepti (eptinezumab) into China and Asia via the SUNLIGHT trial has failed to meet primary endpoints, according to the firm’s Q2 2022 financial report and subsequent earnings call. The drug, approved in the US in February 2020 and in Europe in January 2022, saw…
