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GSK’s Arexvy Receives MHLW Approval for Expanded RSV Indication in Japan
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UK-based pharmaceutical company GlaxoSmithKline (GSK; NYSE: GSK) has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved an expansion of the indication for Arexvy to include adults aged 50-59 who are at an increased risk of respiratory syncytial virus (RSV) infection. This marks a significant step in…
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China Resources Double-Crane Gets NMPA Approval for Semaglutide Biosimilar Clinical Trial
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China Resources Double-Crane Pharmaceutical Co., Ltd (SHA: 600062) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its biosimilar version of Denmark-based Novo Nordisk’s (NYSE: NVO) weight loss drug semaglutide, which is marketed as Ozempic and Wegovy. The product is set to…
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J&J Submits sBLA to FDA for Subcutaneous Tremfya Regimen in Ulcerative Colitis
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Johnson & Johnson (J&J; NYSE: JNJ) has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for a subcutaneous (SC) induction regimen of Tremfya (guselkumab). The application is based on results from the Phase III ASTRO study and seeks approval for the drug to…
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Servier’s Vorasidenib Approved in Boao Lecheng Medical Zone for Diffuse Gliomas
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French pharmaceutical company Servier’s Voranigo (vorasidenib), an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, has been granted approval for use in the Boao Lecheng medical tourism pilot zone as a clinically urgently needed import drug. This approval comes in response to the pressing clinical needs for treatments targeting diffuse…
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Leads Biolabs’ LBL-024 Earns FDA Orphan Drug Designation for Neuroendocrine Cancer
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China-based Leads Biolabs Inc. has announced that it has obtained Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its anti-PD-L1/4-1BB bispecific antibody, LBL-024. This designation is for the treatment of neuroendocrine cancer, a rare and aggressive form of cancer. Mechanism of Action and Preclinical EfficacyLBL-024…
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Signet Therapeutics’ SIGX1094 Earns Orphan Drug Designation for Gastric Cancer from FDA
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China-based Signet Therapeutics has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its FAK-targeted drug, SIGX1094, which is being developed to treat gastric cancer. This designation highlights the potential impact of SIGX1094 in addressing a significant unmet medical need. SIGX1094:…
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Hanx Biopharmaceuticals Files for IPO on Hong Kong Stock Exchange
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China-based Hanx Biopharmaceuticals (Wuhan) Co., Ltd. has made an initial public offering (IPO) filing to the Hong Kong Stock Exchange (HKSE), with the unit price and other details yet to be disclosed. This move marks a significant step for the company as it seeks to expand its reach and funding…
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MSD Partners with Cancer Foundation of China for HPV Vaccine Donation Program
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has entered into a donation agreement with the Cancer Foundation of China (CFC) to support a cervical cancer prevention and control program. Under this agreement, MSD will donate a total of 81,000 doses of the human papillomavirus (HPV) vaccine to the CFC. The…
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Sciwind Biosciences’ Ecnoglutide Accepted for Review by China’s NMPA for Type 2 Diabetes
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China-based Sciwind Biosciences Co., Ltd has announced that the National Medical Products Administration (NMPA) has accepted its market filing for the Category 1 product ecnoglutide. The targeted indication for this treatment is blood glucose control in adult patients with type 2 diabetes. Ecnoglutide’s Therapeutic Potential and Clinical Trial SuccessEcnoglutide is…
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Three Senior Executives of Henan Topfond Pharmaceutical Under Investigation
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On November 22, China General Technology (Group) Holding released three official announcements through its official channels, all concerning the investigation of senior executives at Henan Topfond Pharmaceutical Co., Ltd. (SHA: 600253). The details are as follows: Background on Henan Topfond PharmaceuticalEstablished in 1969, Henan Topfond Pharmaceutical is a large-scale comprehensive…
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Leman Biotech Enters Zhongshan Life Science Park to Accelerate CAR-T Innovation
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Innovative biotechnology company Leman Biotech, focused on cutting-edge cell therapy technology, has announced its official move to Zhongshan Life Science Park on November 21. This relocation marks a significant step forward in the development of a novel automated, fully enclosed CMC process for ultra-low dose CAR-T (chimeric antigen receptor T…
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BRL Medicine Inc. Secures Nearly $30 Million in B+ Round Financing to Advance Pipeline
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On November 22, 2024, BRL Medicine Inc. announced the completion of nearly 200 million yuan in B+ round financing. The round was led by CSCP Fund, with follow-on investments from institutions including Beta Fund. With this funding, BRL Medicine will accelerate the clinical translation and commercialization of its multi-pipeline products…
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Chinese Biopharma Bio-Bank Corp. Aims for HKEX IPO, Focused on PDGF Therapies
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On November 22, 2024, B&K Corporation Limited (Bio-Bank Corp.), a biopharmaceutical company headquartered in China, has resubmitted its application for listing on the Hong Kong Stock Exchange (HKEX). The company is advised by joint sponsors Hua Tai International and CITIC Securities. Company Background and Therapeutic FocusFounded in 2012, Bio-Bank Corp.…
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HutchMed Anticipates Milestone Payment as Takeda Launches Fruzaqla in Japan for CRC
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China-based HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) is poised to receive a milestone payment from its partner Takeda (TYO: 4502), following the successful pricing approval and launch of Fruzaqla (fruquintinib) 1mg/5mg capsules in Japan. The drug is indicated for patients with previously treated metastatic colorectal cancer (CRC). Fruzaqla’s Approval…
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First Patient Dosed in Abbisko’s Phase II Trial of ABSK061 and ABSK043 in FGFR2/3 Altered Tumors
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced the first patient dosing in an open, multi-center Phase II study. The study is designed to assess the safety and efficacy of its investigational drugs ABSK061 combined with ABSK043, with or without chemotherapy, in patients with metastatic or unresectable solid…
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Bayer’s Nubeqa Files for FDA Approval in mHSPC
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German pharmaceutical company Bayer AG (ETR: BAYN) has announced that the US Food and Drug Administration (FDA) has accepted its supplemental new drug application (sNDA) for Nubeqa (darolutamide) for review. Bayer is seeking approval for its androgen receptor inhibitor (ARi) in combination with androgen deprivation therapy (ADT) for the treatment…
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MSD China to Streamline Diabetes Business Amid Volume-Based Procurement Inclusion
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The China unit of US pharmaceutical giant Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) is reportedly streamlining its diabetes business through redundancies, according to local media outlet Yicai. This move is a response to the anticipated impact of the inclusion of its sitagliptin and other drugs in China’s volume-based…
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Zai Lab Ltd Partners with Pfizer for Commercialization of Xacduro in China
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China-based biotechnology company Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) has announced a strategic collaboration agreement with global pharmaceutical giant Pfizer (NYSE: PFE). The partnership grants Pfizer’s affiliated companies the exclusive rights to commercialize Xacduro (durlobactam, sulbactam) in mainland China. This collaboration, set to be in effect through November 2028,…
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China Grants Marketing Approval for MSD’s Welireg for von Hippel-Lindau Disease Tumors
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China’s National Medical Products Administration has issued marketing approval for Merck, Sharp & Dohme’s (MSD; NYSE: MRK) oral drug Welireg (belzutifan) as a therapy for von Hippel-Lindau (VHL) disease-related renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastoma, and pancreatic neuroendocrine tumor (pNET) that do not require immediate surgical intervention.…
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Medtronic Reports 5% Organic Revenue Growth in Q2 FY25 with Strong Portfolio Performance
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US-Irish medical device company Medtronic (NYSE: MDT) has announced its financial results for the second quarter (Q2) of fiscal year 2025, which concluded on October 25, 2024. The company reported a total revenue of USD 8.403 billion for the period, marking a 5.0% increase on an organic basis. Cardiovascular Portfolio…
