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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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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).…
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ClouDr Partners with Ipsen to Expand Diphereline’s Reach in China
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Hangzhou Kang Ming Information Technology Co., Ltd (HKG: 9955), known as “ClouDr,” has partnered with French pharmaceutical company Ipsen S.A. (Euronext: IPN; ADR: IPSEY) regarding Ipsen’s Diphereline (triptorelin), a natural gonadotropin-releasing hormone (GnRH) agonist analog. Financial details of the partnership were not disclosed. ClouDr is a one-stop chronic disease management…
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E-Health Now Raises Funds for Oncology and Cardiovascular Digital Health Products
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E-Health Now, a Beijing-based commercial insurance-focused health management service solutions provider, has raised an undisclosed amount of funds in a Series A++ financing round. The round was led by Borchid Capital, with participation from Tongji Fund. The proceeds will be used for the research and development of specialty digital health…
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KingYee and XINSEC IOT Form Strategic Partnership for Smart Ward Solutions
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Shanghai-based KingYee, a leading domestic intelligent medical technology and service provider, has entered into a strategic investment and collaboration agreement with XINSEC IOT, a medical internet of things (IoT) application specialist based in Guangdong. KingYee will invest in XINSEC, and the two companies will work together on the creation of…
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Chongqing Pharscin’s Gabexate Mesylate Passes GQCE as First Generic in China
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China-based Chongqing Pharscin Pharmaceutical Co., Ltd (SHE: 002907) announced that its gabexate mesylate has passed the generic quality consistency evaluation (GQCE), making it the first generic version of the drug to achieve this status in China. The drug is used to treat acute mild (edematous) pancreatitis and as adjuvant therapy…
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Bennu Biotherapeutics Raises Over RMB100m in Angel+ Round for Global Pipeline Development
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Shanghai-based cell therapy specialist Bennu Biotherapeutics has raised over RMB100 million (USD14.8 million) in an angel+ financing round. The round was led by INCE Capital and included contributions from Life Science Park Innovation Investment Fund and Witruth Capital. The proceeds will be used to advance the pre-clinical and clinical development…
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Sunshine Guojian’s SSGJ-608 Hits Primary Endpoint in Psoriasis Study
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China-based Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, a subsidiary of 3SBio Inc. (HKG: 1530), announced that its randomized, double-blind, placebo-controlled, multi-dose escalation and dose exploration Phase II clinical study for the anti-IL-17A monoclonal antibody (mAb) SSGJ-608 in moderate to severe plaque psoriasis has reached its primary endpoint. Study DetailsThe study,…
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Zelgen Biopharmaceuticals’ Donafenib Receives NMPA Approval for Thyroid Cancer
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China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that the supplementary New Drug Application (sNDA) for its Category 1 anti-cancer drug donafenib in locally advanced / metastatic radioiodine-refractory differentiated thyroid cancer (RAIR-DTC) has been approved by the National Medical Products Administration (NMPA). This is the second indication approval for…
