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DaAn Gene Co., Ltd Receives NMPA Approval for Genetic Deafness Gene Detection Kit
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China-based DaAn Gene Co., Ltd, (SHE: 002030) affiliated with Sun Yat-sen University, has announced that it has received a Category III medical device license from the National Medical Products Administration (NMPA) for its genetic deafness gene detection kit, which employs PCR flow cytometry fluorescence hybridization methodology. Advanced Technology for Genetic…
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MediLink Therapeutics’ YL201 Receives FDA Orphan Drug Designation for Small-Cell Lung Cancer
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Suzhou-based biotech company MediLink Therapeutics (Suzhou) Co., Ltd has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for its antibody drug conjugate (ADC) YL201 for the treatment of small-cell lung cancer (SCLC). This designation highlights the potential impact of YL201 in addressing a…
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BMS Regains Exclusive Rights to ABZ-706 in Greater China
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Bristol-Myers Squibb (BMS; NYSE: BMY) has reached an agreement with China-based Ablaze Pharmaceuticals to regain exclusive development and commercialization rights for ABZ-706 in Greater China, which includes mainland China, Hong Kong, Macau, and Taiwan. ABZ-706 is a targeted therapy for liver cancer that focuses on the GPC3 biomarker. Background on…
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Everest Medicines’ Nefecon Receives First Prescription for IgAN Treatment in Adults
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China-based Everest Medicines (HKG: 1952) has announced that its targeted-release budesonide, Nefecon, has been prescribed for the first time to treat primary immunoglobulin A nephropathy (IgAN) in adults who are at risk of disease progression. This development signifies a significant step forward in the management of IgAN, a condition that…
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FDA Approves Xcovery Holdings’ Ensartinib for Untreated ALK-Positive NSCLC Patients
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On December 18, 2024, the Food and Drug Administration (FDA) granted approval for Betta Pharmaceutical (SHE: 300558) and its controlling subsidiary Xcovery Holdings, Inc.’s ensartinib (Ensacove), a treatment for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received…
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INT Medical Instruments to Acquire Controlling Stake in Weiqiang Medical Technology for RMB 230 Million
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Shanghai INT Medical Instruments Co., Ltd. (HKG: 1501) has announced its intention to acquire at least a 51% stake in its Chinese counterpart, Hangzhou Weiqiang Medical Technology Co.,Ltd. The acquisition will see INT Med make an initial upfront payment of RMB 30 million (USD 4.11 million), along with a substantial…
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Janssen-Cilag Submits for IMBRUVICA Indication Extension in Untreated Mantle Cell Lymphoma
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Janssen-Cilag International NV has announced the submission seeking approval for an indication extension of IMBRUVICA (ibrutinib) in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP). The extended indication is for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are eligible for autologous stem cell…
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iFlytek’s Subsidiary Xunfei Healthcare Technologies Lists on HKEX, Raises Over HKD 580 Million
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Xunfei Healthcare Technology Co., Ltd, a subsidiary of China-based information technology company iFlytek Co., Ltd (SHE: 002230), has officially launched its initial public offering (IPO) on the Hong Kong Stock Exchange. The company issued 7,035,550 shares at a price of HKD 82.8 per share, securing over HKD 580 million (USD…
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Chengdu Kanghua Biological Receives NMPA Approval for Recombinant Norovirus Vaccine
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Chengdu Kanghua Biological Products Co., Ltd, (SHE: 300841), a leading biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its recombinant hexavalent norovirus vaccine (Pichia pastoris). The vaccine is designed to prevent acute gastroenteritis caused by genotype…
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Sinocare Inc’s TRUE VIE CGMS Advances to 510(k) Substantive Review Stage at FDA
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Sinocare Inc (SHE: 300298), a China-based medical technology company, has announced that its continuous glucose monitoring system (CGMS), TRUE VIE CGMS, has entered the 510(k) substantive review stage at the US Food and Drug Administration (FDA). This milestone follows the successful passage of the initial acceptance review for the FDA…
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Huadong Medicine’s HDM1005 Receives FDA Clearance for Heart Failure and Obesity Clinical Trial
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received clearance from the US Food and Drug Administration (FDA) for its Category 1 chemical drug, HDM1005. The drug will now proceed to clinical trials involving patients with heart failure with preserved ejection fraction (HFpEF) and obesity. HDM1005:…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for SHR-1501 Combo in Bladder Cancer
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), a leading China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for the combination of SHR-1501 with adebrelimab (SHR-1316) for the treatment of non-muscle invasive bladder cancer. Adebrelimab: A PD-L1 Monoclonal Antibody with…
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Sino Biopharmaceutical’s Benmelstobart Meets Primary Endpoint in Phase III NSCLC Study
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading China-based biopharmaceutical company, has announced positive results from the Phase III study (TQB2450-Ⅲ-05) for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450). The study evaluated benmelstobart, with or without multi-target kinase inhibitor anlotinib, as a consolidation therapy for locally advanced/unresectable (stage…
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Hansoh Pharmaceutical Secures Global Licensing Deal with Merck for HS-10535
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China’s Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced a significant global license deal with US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) concerning its investigational oral molecule, HS-10535, a GLP-1 receptor agonist. Terms of the Agreement and Financial ImplicationsAccording to the agreement, Merck will secure exclusive…
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UCB’s Minzasolmin Fails to Meet Endpoints in ORCHESTRA Study for Early Parkinson’s
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Belgium-based biopharmaceutical company UCB (EBR: UCB) has announced the disappointing results of the ORCHESTRA proof-of-concept (POC) study for minzasolmin, an alpha-synuclein misfolding inhibitor co-developed with Swiss pharmaceutical giant Novartis (NYSE: NVS). The study was designed to assess the efficacy of minzasolmin in treating early Parkinson’s disease, but it failed to…
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HealthyWay Inc. Completes HKD 220 Million IPO on the Hong Kong Stock Exchange
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China-based HealthyWay Inc. (HKG: 2587) has made a significant debut on the Hong Kong Stock Exchange with an initial public offering (IPO) of 25 million shares, priced at HKD 8.8 per share. This translates to a capital raise of HKD 220 million (USD 28.3 million), marking a significant milestone for…
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Sino Biopharmaceutical and Sinopharm Group Collaborate to Expand Retail Pharmacy Network
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In a significant move for China’s pharmaceutical industry, Sino Biopharmaceutical Ltd (HKG: 1177) and Sinopharm Group Co., Ltd (HKG: 1099) have announced a strategic partnership to delve into the ex-hospital market. This collaboration will capitalize on Sino Biopharmaceutical’s extensive product portfolio and Sinopharm Group’s robust retail presence, including GuoDa Drugstore…
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Everest Medicines’ Velsipity (Etrasimod) Receives First Prescription in Foshan under GBA Policy
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Everest Medicines (HKG: 1952), a leading biopharmaceutical company based in China, has announced that its Velsipity (etrasimod) has been prescribed for the first time at Foshan Fosun Chancheng Hospital. This prescription was made possible under the “Hong Kong-Macau Drug and Device Access” policy, which is part of the Greater Bay…
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ImmuneOnco Biopharmaceuticals Initiates Phase Ib Study for Amulirafusp Alfa in NMOSD
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ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKG: 1541), a China-based biopharmaceutical company, has announced the commencement of a Phase Ib study for its innovative dual-target macromolecular drug, amulirafusp alfa (IMM0306), in patients with neuromyelitis optica spectrum disorders (NMOSD). This marks a significant step as the first patient has been dosed in the…
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Henlius Biotech Joins Biosimilars Forum to Expand Global Biosimilars Access
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Shanghai Henlius Biotech Inc. (HKG: 2696), a leading Chinese biopharmaceutical company, has announced its membership in the Biosimilars Forum, a nonprofit organization dedicated to advancing the biosimilars industry in the United States. The membership aims to expand access to biological medicines and improve healthcare outcomes. Henlius anticipates that this membership…
