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Shanghai Ark Biopharmaceutical Partners with WuXi STA for Commercial Supply of Ziresovir
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China’s Shanghai Ark Biopharmaceutical Co., Ltd. (ArkBio) has entered into a partnership with WuXi STA, a subsidiary of WuXi AppTec, for the commercial supply of ziresovir, a novel treatment for respiratory syncytial virus (RSV) infections. Ziresovir: A First-in-Class RSV Fusion InhibitorZiresovir, a first-in-class small molecule RSV fusion (F) protein inhibitor,…
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Sino Biopharmaceutical’s TQ-B3525 Files for Market Approval with CDE
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Sino Biopharmaceutical Ltd (HKG: 1177) has announced a market approval filing for its Category 1 anti-tumor drug, TQ-B3525, a phosphatidylinositol3-kinase (PI3-K) α/δ inhibitor. The filing has been accepted for review by China’s Center for Drug Evaluation (CDE), with the intended indication being the treatment of recurrent/refractory follicular lymphoma (FL) as…
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MabPharm’s CMAB007 Receives NMPA Approval for IgE-Mediated Asthma Treatment
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Taizhou-based monoclonal antibody (mAb) biosimliars specialist MabPharm Ltd (HKG: 2181) has announced that it has attained market approval from the National Medical Products Administration (NMPA) for its CMAB007, a biosimilar version of Roche/Genentech’s anti-IgE dermatology and asthma therapy omalizumab (trade name: Xolair). This approval marks the first home-grown therapeutic biologic…
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Alibaba Health Reports 30.1% Revenue Growth in 2022 Financial Report
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China-based Alibaba Health Information Technology Ltd (HKG: 0241) has released its financial report for the year ended March 31, 2023, recording RMB 26.763 billion (USD 3.8 billion) in revenue, marking a 30.1% year-on-year (YOY) increase. The company’s net profit for the year reached RMB 534 million (USD 76 million), a…
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Enhertu, HER2-Targeted ADC, Officially Launched in China for Breast Cancer Treatment
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Enhertu (trastuzumab deruxtecan), a HER2-targeted antibody-drug conjugate (ADC) co-developed by AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), has been officially launched in the Chinese market. The drug received marketing approval in China in February 2023 and is now available for the treatment of unresectable or metastatic HER2 positive…
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BeiGene’s Tislelizumab Approved in China for First-Line Esophageal Squamous Cell Carcinoma
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BeiGene (NASDAQ: BGNE) has announced that its programmed death-1 (PD-1) inhibitor, tislelizumab, has been approved in China as a first-line therapy for non-resectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). This approval comes as part of a combination therapy including chemotherapy regimens of paclitaxel and platinum or…
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Bayer’s Copanlisib (Aliqopa) Approved by NMPA for Recurrent Follicular Lymphoma
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The National Medical Products Administration (NMPA) has indicated on its website that Bayer’s (ETR: BAYN) copanlisib (trade name: Aliqopa) has been granted approval as a monotherapy treatment for recurrent or refractory follicular lymphoma (FL) in China. This approval is specifically for patients who have failed at least two previous systemic…
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Azenta Life Sciences and Vazyme Biotech Form Global Partnership for Comprehensive Services
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Azenta Life Sciences (NASDAQ: AZTA) has entered into a global partnership with China-based Vazyme Biotech Co., Ltd (SHA: 688105) to enhance their joint “one-stop” service process. This collaboration covers a wide range of fields, including high-throughput sequencing, automated database building, raw material supply, experimental consumables, and sample storage. Financial details…
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3SBio Inc. Initiates Phase III Clinical Study for Thrombopoietin in Chronic Liver Disease Patients
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China-based 3SBio Inc. (HKG: 1530) has announced the enrollment of the first patient in a Phase III clinical study for its thrombopoietin, which is being assessed for the treatment of thrombocytopenia in patients with chronic liver disease who are planned for invasive surgery. Background of 3SBio’s Thrombopoietin (TPIAO)Developed in-house, 3SBio’s…
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Shanghai Junshi Biosciences’ Tuoyi Combo for Triple Negative Breast Cancer Accepted for Review
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that the regulatory authorities have accepted for review another indication approval filing for its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) combined with paclitaxel (albumin bound) for the treatment of PD-L1 positive (CPS ≥ 1) primary metastatic or recurrent metastatic…
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Oculis’ OCS-01 Achieves Primary Efficacy Endpoint in Phase III DIAMOND Trial for DME
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US-based Oculis Holding AG (NASDAQ: OCS) has announced positive top-line results from Stage 1 of its Phase III DIAMOND trial for the eye drop drug candidate OCS-01, which is being assessed as a treatment for diabetic macular edema (DME). The trial data indicate that the drug achieved its primary efficacy…
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Nona Biosciences and ModeX Therapeutics Partner to Develop Polyspecific Antibodies
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Nona Biosciences, a wholly owned subsidiary of Harbour BioMed (HKG: 2142), which operates across the Netherlands, the United States, and China, has announced a strategic partnership with OPKO Health’s subsidiary, ModeX Therapeutics. The collaboration will fully leverage Nona Bio’s Harbor Mice whole human transgenic mouse platform technology for the development…
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SinoMab BioScience’s SM17 IND Accepted by NMPA for Potential Global First-in-Class Monoclonal Antibody
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Hong Kong-based biotech SinoMab BioScience Ltd (HKG: 3681) has announced that the National Medical Products Administration (NMPA) has accepted for review an investigational new drug (IND) filing for SM17, a potential global first-in-class monoclonal antibody. Developed in-house by SinoMab, SM17 is the world’s first humanized IgG4-κ monoclonal antibody targeting IL-17RB,…
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JW Therapeutics Secures Supply Agreement with Juno to Advance CAR-T Therapy Commercialization
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China-based JW Therapeutics (HKG: 2126) has announced a carrier supply agreement with its shareholder Juno, aimed at supporting the continuous commercialization and further clinical development of its chimeric antigen receptor (CAR) T cell therapy, Carteyva (relmacabtagene autoleucel injection). Financial Terms and ProjectionsThe agreement outlines that from the effective date of…
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HighTide Therapeutics’ HTD1801 Meets Primary and Secondary Endpoints in Type 2 Diabetes Phase II Study
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China-based HighTide Therapeutics Inc. (HKG: 2511) has announced that its Phase II study for the drug candidate HTD1801 (berberine ursodeoxycholate, BUDCA) as a treatment for type 2 diabetes (T2DM) has achieved its primary endpoint and several important secondary endpoints. The study demonstrated that treatment with HTD1801 resulted in a superior…
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GenScript Biotech’s Legend Biotech Secures Private Placement with Hillhouse Investment
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China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has revealed that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), is set to conduct a private placement of 692,800 shares at USD 32 per share to LGN Holdings Ltd, a company solely managed by Hillhouse Investment Management, Ltd. This transaction…
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Zhejiang Conba Pharmaceutical’s Inhalable Pirfenidone for IPF Clears for Chinese Clinical Trials
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Zhejiang Conba Pharmaceutical Co., Ltd (SHA: 600572) has announced that its modified version of US firm Marnac’s pirfenidone, in the form of an inhalable solution, has been approved for clinical trials in China. The drug is aimed at treating idiopathic pulmonary fibrosis (IPF), a progressive lung disease characterized by diffuse…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for Two Autoimmune Disease Drug Candidates
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has separately announced clinical trial approvals from the National Medical Product Administration (NMPA) for two of its drug candidates, SHR-1654 and SHR-2001. These molecules are set for assessment as potential treatments for rheumatoid arthritis and systemic lupus erythematosus, respectively. SHR-1654: A Novel Treatment for…
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Sino-US Laekna Receives FDA Clearance for LAE102 Clinical Trial in NSCLC
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Sino-US Laekna has announced that it has received clinical trial clearance from the US Food and Drug Administration (FDA) for its LAE102 antibody. The drug is set to be assessed as a potential treatment for non-small cell lung cancer (NSCLC). This achievement marks LAE102 as Laekna’s first internally-discovered drug candidate…
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Lundbeck A/S Reports Record Quarterly Revenue in Q1 2023 with 11% YOY Increase
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Denmark-based pharmaceutical company Lundbeck A/S (OTCMKTS: HLUBF) has released its financial report for the first quarter of 2023, highlighting an 11% year-on-year (YOY) increase in global sales revenues in constant exchange rate terms, reaching DKK 5.044 billion (USD 731.2 million). This figure marks the highest quarterly revenue in the company’s…
