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Mabwell’s 6MW3511 Accepted by NMPA for Advanced Solid Tumor Treatment
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced that a clinical trial filing for its 6MW3511 has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant milestone for the company’s innovative oncology pipeline. Drug Mechanism and Innovation6MW3511 is a bifunctional protein linking an…
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NMPA Approves 164 Medical Devices in May 2022, Including Medtronic and Boston Scientific Products
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The National Medical Products Administration (NMPA) approved a total of 164 medical devices for marketing in May 2022. The approvals included 109 domestic Class III products, 23 imported Class III products, 30 imported Class II products, and 2 products from “special administrative regions.” Notable ApprovalsAmong the approved devices were offerings…
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Boao Lecheng Sees Surge in Drug Use and Medical Tourism Amid Global Partnerships
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The Boao Lecheng Medical Tourism Pilot Zone reported a significant increase in special drug and device users, up 431% year-on-year (YOY) in 2021. Medical tourist numbers surged 90.57% YOY to 127,300, according to China News, with the area welcoming 40,000 medical tourists in Q1 of this year, marking a 60%…
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Takeda’s Obizur Accepted by China’s NMPA for Acquired Hemophilia A Treatment
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Takeda Pharmaceutical Co., Ltd’s (NYSE: TAK, TYO: 4502) China unit announced that a New Drug Application (NDA) filing for its Obizur (susoctocog alfa) has been accepted for review by the National Medical Products Administration (NMPA). The drug is intended for use as an on-demand treatment and prevention of bleeding in…
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Sirnaomics’ STP705 Shows Promising Results in Skin Cancer Trial
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Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) announced the peer-reviewed publication of Phase IIa clinical study results of its lead therapeutic candidate, STP705, for the treatment of skin cancer, in the May 2022 issue of the Journal of Drugs in Dermatology (the “JDD”). Clinical Trial ResultsThe single-center, open-label, dose-escalation…
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Joincare Pharmaceutical Plans USD 300-400 Million GDR Issue for Global Expansion
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China-based Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380) announced plans to issue Global Depository Receipts (GDRs) on the SIX Swiss Exchange. The proceeds will be used to support international business development and accelerate global expansion. The fundraising size is expected to be in the region of USD 300-400 million,…
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HitGen Inc. Forms Strategic Partnership for New Drug Research and Development
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China-based HitGen Inc. (SHA: 688222) announced the establishment of a strategic partnership with compatriot firm Health Sky Pharmaceutical. The collaboration aims to leverage their respective technology and resource advantages to jointly pursue new drug research and development, pre-clinical and clinical studies, and program incubation. Partnership DetailsHitGen brings to the table…
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Yabao Pharmaceutical’s YBSW015 Gets Australian Ethical Approval for COVID-19 Trial
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China-based Yabao Pharmaceutical Group Co., Ltd (SHA: 600351) has announced that it has received clinical trial ethical approval in Australia to conduct a Phase I clinical study for its YBSW015, a bispecific neutralizing antibody against SARS-CoV-2 developed to treat COVID-19 infection. Mechanism of ActionYBSW015 is a bispecific antibody (BsAb) targeting…
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Suzhou Zelgen’s JAK Inhibitor Jacktinib Gets NMPA Green Light for COVID-19 Trial
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China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 Janus kinase (JAK) inhibitor, jacktinib, in patients with severe COVID-19. Mechanism of ActionJacktinib works by blocking the signal transducer…
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Sichuan Kelun’s KL340399 Wins NMPA Approval for Solid Tumor Trials
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China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its next-generation small-molecule STING agonist, KL340399. The approval allows the company to proceed with trials for locally advanced, recurrent, or metastatic solid tumors suitable for intratumoral injection. Drug Mechanism…
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WinHealth Pharma and Ferring Partner to Co-Promote Pentasa in China
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China-based Hong Kong WinHealth Pharma Group Ltd has entered into a new partnership with Switzerland-headquartered Ferring Pharmaceuticals Ltd, this time securing co-promotion rights for Ferring’s Pentasa (mesalazine) in mainland China. This collaboration follows previous joint efforts on terlipressin and desmopressin. Partnership DetailsUnder the terms of the agreement, WinHealth Pharma will…
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WuXi ATU Partners with Wugen to Accelerate NK Cell Therapy Development
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WuXi ATU, the gene and cell therapy-focused CTDMO unit of WuXi Apptec (SHA: 603259, HKG: 2359), has formed a partnership with US clinical biotech firm Wugen, Inc. This collaboration centers on Wugen’s immunotherapy candidate WU-NK-101, with WuXi ATU providing Good Manufacturing Practice (GMP)-compliant manufacturing and testing services to support regulatory…
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Jiangsu Hengrui Medicine’s SHR4640 Receives NMPA Approval for Gout Trial
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 innovative gout drug SHR4640. The study will evaluate the drug in combination with febuxostat for hyperuricemia in gout patients. Drug MechanismSHR4640 is…
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Beijing Aosaikang’s ASKG315 Receives NMPA Approval for Solid Tumor Trial
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) announced that its clinical trial application for ASKG315, an in-house developed recombinant human interleukin-15 prodrug Fc fusion protein, has been accepted by China’s National Medical Products Administration (NMPA). This marks a significant milestone for the company’s oncology pipeline. Drug Mechanism and InnovationASKG315 is…
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Jacobson Pharma Leads HKD 6 Million JV for Specialty Drug Distribution
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China-based Jacobson Pharma Corporation (HKG: 2633), Ban Loong Holdings Ltd (HKG: 0030), and JBM (Healthcare) Limited (HKG: 2161) are set to establish a joint venture (JV) with a capital of HKD 6 million (USD 764,361). The companies will hold stakes of 20%, 60%, and 20% respectively. The JV aims to…
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Hansoh Pharmaceutical’s Ameile Accepted for UK Regulatory Review
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that a Marketing Authorization Application (MAA) for its epidermal growth factor receptor (EGFR) inhibitor Ameile (almonertinib) has been accepted for review by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The application seeks approval for Ameile as a first-line treatment…
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MegaRobo Secures USD 300 Million in Series C Round Led by Goldman Sachs
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Beijing-based MegaRobo Technologies, a company applying robotics and artificial intelligence (AI) in the life sciences field, has reportedly secured USD 300 million in a Series C financing round. The funding was led by Goldman Sachs, GGV Capital, and Asia Investment Capital, with participation from Sinovation Ventures, Pavilion Capital, Starr Capital,…
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China Issues Monkeypox Diagnosis Guidelines Amid Global Outbreaks
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China’s National Health Commission (NHC) has formulated and released the “Monkeypox Diagnosis and Treatment Guidelines” (2022 Edition) in response to the recent outbreaks of monkeypox in multiple non-pandemic countries since May this year. The guidelines aim to enhance early clinical identification and standardized diagnosis and treatment, ensuring thorough preparedness against…
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Quoin Pharmaceuticals Partners with WinHealth for Rare Disease Treatments in Greater China
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US-based rare disease specialist Quoin Pharmaceuticals Ltd (NASDAQ: QNRX) announced a licensing and distribution agreement with Hong Kong WinHealth Pharma Group Ltd. The deal grants WinHealth rights to Quoin’s pipeline candidates QRX003 and QRX004 for Netherton syndrome and epidermolysis bullosa (EB) in the Greater China territory, including Hong Kong, Macau,…
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US Bipartisan Bill Seeks to Regulate Investments in Chinese High-Tech Firms
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US senators are preparing a bipartisan bill that would require US investors targeting Chinese high-tech companies, including those in the pharmaceutical sector, to seek government approval in the future. The draft proposals are part of an economic competitiveness bill aimed at countering China’s rise. Proposed MechanismThe proposals would establish a…
