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Belief-Delivery BioMed’s BBM-H901 Granted BTD for Hemophilia B Prevention
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The Center for Drug Evaluation (CDE) website indicates that Shanghai Belief-Delivery BioMed Co., Ltd’s injectable BBM-H901 has been granted breakthrough therapy designation (BTD) status. The drug is approved for use in preventing bleeding in adult male patients with hemophilia B (congenital factor IX deficiency). Drug DetailsBBM-H901 is a Category 1…
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Wyze Biotech Raises RMB59m to Advance DNT Cell Therapies
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Wyze Biotech Co., Ltd, a Guangdong-based developer of off-the-shelf universal DNT cell therapies, has reportedly raised RMB59 million (USD8.7 million) in a Series A + financing round. The round was led by Utrust Fund and Baidu Venture, among others. The proceeds will support the research and development of off-the-shelf universal…
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Sanjin Pharma’s Subsidiary Gets NMPA Nod for BC007 Cancer Study
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China-based Guilin Sanjin Pharmaceutical Co. Ltd (SHE: 002275) announced that its subsidiary, Dragon Boat Biopharmaceutical (Shanghai) Co., Ltd, has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study of BC007. The study will assess the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor efficacy…
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I-Mab and AbbVie End CD47 Antibody Trial but Continue Collaboration
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China-based biotech I-Mab (NASDAQ: IMAB) filed with the US Securities and Exchange Commission (SEC) that its co-development partner AbbVie Inc. (NYSE: ABBV) has decided to end a Phase Ib clinical trial of the CD47 monoclonal antibody (mAb) lemzoparlimab. The trial, which assessed the drug in combination with azacitidine and venetoclax,…
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Menovo Pharmaceutical Plans RMB892m Private Placement to Boost API Production
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China-based Ningbo Menovo Pharmaceutical Co., Ltd (SHA: 603538) has announced plans to raise up to RMB892 million (USD131.6 million) through a private placement. The net proceeds will be used for the creation of an active pharmaceutical ingredients (APIs) and intermediates program with an annual output of 3,760 tons, as well…
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BeiGene Partners with Ontada to Accelerate RWE Development in US Oncology Market
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China-based biotech company BeiGene (HKG: 6160, SHA: 688235, NASDAQ: BGNE) announced that it has signed a strategic agreement with Ontada, a subsidiary of McKesson Corporation, to accelerate the development and use of real-world evidence (RWE) in support of BeiGene’s oncology products in the US market. The financial details of the…
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Grand Pharmaceutical’s Carglumic Acid Set for Priority Review by CDE
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The Center for Drug Evaluation (CDE) website indicates that China-based Grand Pharmaceutical Group Limited’s (HKG: 0512) generic carglumic acid is set for priority review. The indications include hyperammonemia due to N-acetylglutamate synthase deficiency, hyperammonemia due to isovaleric acidemia, hyperammonemia due to methylmalonic acidemia, and hyperammonemia due to propionic acidemia. Reason…
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Ascletis Pharma’s Gannex Initiates DDI Study for ASC42 in PBC
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Ascletis Pharma Inc. (HKG: 1672) announced that its wholly – owned US unit, Gannex, has initiated the first subject dosing in a drug – drug interaction (DDI) study for its drug candidate ASC42 in primary biliary cholangitis (PBC) in the United States. The study is designed to provide additional evidence…
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Venus Medtech’s VenusP-Valve Used Again in US Compassionate Case
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Venus Medtech (Hangzhou) Inc. (HKG: 2500) announced the second US market compassionate use of its VenusP-Valve, a transcatheter pulmonary valve replacement (TPVR) system. The system is intended to treat patients with moderate to severe pulmonary regurgitation with or without right ventricular outflow tract (RVOT) stenosis. The procedure was conducted at…
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Luye Pharma’s Goserelin Acetate Injectable Accepted for Breast Cancer Review
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China-based Luye Pharma Group (HKG: 2186) announced that another market filing for its goserelin acetate sustained-release injectable microspheres (LY01005) as a treatment for breast cancer has been accepted for review by China’s Center for Drug Evaluation (CDE). The drug is already under review for its use in treating prostate cancer.…
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Healthnice Pharma Raises RMB100m to Expand Product Pipeline and R&D Team
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China-based Nanjing Healthnice Pharmaceutical Technology Co., Ltd has reportedly raised RMB100 million (USD14.8 million) in another financing round. The round was led by CICC ChuanHua Industrial Equity Investment Fund, with other investors including Sunland Fund and Jiangxi State-owned Industry Development Fund. The proceeds will be used for product pipeline layout…
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Healthnice Pharma Raises RMB100m to Expand Product Pipeline and R&D Team
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China-based Nanjing Healthnice Pharmaceutical Technology Co., Ltd has reportedly raised RMB100 million (USD14.8 million) in another financing round. The round was led by CICC ChuanHua Industrial Equity Investment Fund, with other investors including Sunland Fund and Jiangxi State-owned Industry Development Fund. The proceeds will be used for product pipeline layout…
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Gilead Transfers Trodelvy Asian Rights to Everest Medicines for USD280m
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US pharmaceutical major Gilead Sciences Inc. (NASDAQ: GILD) today announced an agreement with Everest Medicines (HKG: 1952) to transfer the development and commercialization rights for Trodelvy (sacituzumab govitecan) in Asian territories. Trodelvy is a TROP-2 targeted antibody drug conjugate (ADC). The deal regains control of the drug’s Asian rights for…
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CDE Prioritizes Review for Sanofi’s Nexviazyme and WinHealth’s Ravicti
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The Center for Drug Evaluation (CDE) website indicates that two drugs have been selected for priority review status. The selected products are French giant Sanofi’s Nexviazyme (avalglucosidase alfa) and China-based Hong Kong WinHealth Pharma Group Ltd’s Ravicti (glycerol phenylbutyrate). Nexviazyme DetailsNexviazyme is an investigational enzyme replacement therapy (ERT) developed by…
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Henlius Biotech’s HanBeiTai sBLA Accepted for HCC Treatment Review
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced that a supplementary Biologic License Application (sBLA) for its HanBeiTai, a biosimilar of Roche’s Avastin (bevacizumab), has been accepted for review by the Center for Drug Evaluation (CDE). The targeted indication is hepatocellular carcinoma (HCC). Drug BackgroundHanBeiTai is also awaiting a regulatory decision…
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Alphamab Oncology Doses First Patient in KN046-209 Study for NSCLC
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China-based Alphamab Oncology (HKG: 9966) announced the first patient dosing in the multi-center, open-label Phase II KN046-209 study. The trial evaluates the efficacy, safety, and tolerability of KN046 (erfonrilimab) combined with axitinib in first-line locally advanced or metastatic PD-L1-positive (TPS ≥ 1%) non-small cell lung cancer (NSCLC) patients who have…
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Roche’s Rozlytrek Wins NMPA Approval for ROS1+ NSCLC Treatment
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Swiss pharmaceutical giant Roche’s China unit announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Rozlytrek (entrectinib). The approved indication is for the treatment of ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Drug BackgroundEntrectinib, the first ROS1 inhibitor with…
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EQRx Accelerates US Development of Two Chinese-Licensed Cancer Drugs
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US-based pharma EQRx Inc. (Nasdaq: EQRX) has revealed its latest plans to accelerate the US market development of two innovative drugs licensed from Chinese partners. The company’s Q2 2022 financial report shows that a US-led Phase IIIb bridging study has recently been initiated for aumolertinib as a first-line treatment of…
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Novartis Aims for China to Be Second – Largest Market by 2024
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Dan Brindle, head of Novartis AG’s (NYSE: NVS) China operations, recently spoke with Xinhua news service about the company’s ambitions in the Chinese market. Brindle expects China to become the multinational corporation’s “second-largest market by 2024.” This goal will be achieved through a series of new product approvals. “In the…
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ESR Group Enters Life Sciences with Zhangjiang NEO Acquisition
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Hong Kong-based real estate asset manager ESR Group Ltd (HKG: 1821) has made its first investment in the life sciences sector by acquiring an R & D business park in Shanghai’s Zhangjiang Hi-Tech Development Zone. The 8,940 sq. m. site, named Zhangjiang NEO, was purchased for RMB268 million (USD39.8 million).…
