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Intas Pharmaceuticals Receives FDA Approval for Biosimilar Stelara, Expanding Treatment Options for Autoimmune Diseases
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Intas Pharmaceuticals Ltd, an Indian pharmaceutical company and partner of China’s Shanghai Henlius Biotech Inc. (HKG: 2696), has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its ustekinumab-srlf. This biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) auto-immune disease drug Stelara…
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RemeGen’s Disitamab Vedotin Receives Priority Review for New Indication in Breast Cancer by China’s NMPA
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RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted another indication approval filing for its drug candidate disitamab vedotin (RC48). The antibody-drug conjugate (ADC) has been granted priority review status. This…
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Lundbeck Secures Rights to Bexicaserin with Acquisition of Longboard Pharmaceuticals
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Lundbeck A/S (VIE: LUNA), a Danish pharmaceutical company, has announced its intention to acquire U.S.-based Longboard Pharmaceuticals, Inc. (NASDAQ: LBPH) in a deal valued at USD 60.00 per share in cash. The transaction, on a fully diluted basis, is worth USD 2.6 billion in equity terms and USD 2.5 billion…
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Stemirna Therapeutics, Once a Leading mRNA Developer in China, Enters Bankruptcy Proceedings
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Stemirna Therapeutics Co., Ltd, a one-time leading mRNA developer in China, has officially commenced bankruptcy proceedings, with the case accepted by the Pudong New Area People’s Court of Shanghai. Established in 2016, Stemirna secured a war chest exceeding RMB 1.5 million through a series of financing rounds from 2020 to…
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AstraZeneca and Daiichi Sankyo’s Enhertu Receives Fourth Indication Approval in China
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AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568)’s co-developed antibody drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), has received conditional approval from China’s National Medical Products Administration (NMPA) for the treatment of adult patients with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors exhibit activating HER2 (ERBB2)…
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BMS’s Dual Immunotherapy Achieves Global First Approval for MSI-H/dMMR CRC in China
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On October 14, 2024, Bristol-Myers Squibb (BMS, NYSE: BMY) announced that the National Medical Products Administration (NMPA) of China has approved a new indication for its dual immune combination therapy, Opdivo (nivolumab) and Yervoy (ipilimumab), for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or deficient…
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Sichuan Biokin Pharmaceutical Gets FDA Approval for CD33-Targeting ADC in Acute Myeloid Leukemia
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Sichuan Biokin Pharmaceutical Co., Ltd, a Chinese pharmaceutical company listed on the Shanghai Stock Exchange as (SHA: 688506), has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study for its antibody-drug conjugate (ADC), BL-M11D1. This therapy targets CD33…
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iRegene Therapeutics Secures Over USD 14 Million in Series B Financing to Advance Cell Therapies
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iRegene Therapeutics, a Wuhan-based biotechnology company specializing in the development of AI-enhanced chemically induced cell therapies, has announced the successful completion of its Series B financing round, raising over RMB 100 million (USD 14.15 million). The financing was co-led by Orinno Capital, with additional investments from Optics Valley Industrial Investment…
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BrightGene’s BGM0504 Shows Promise in Phase II Obesity Study Without Diabetes
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BrightGene Bio-Medical Technology Co., Ltd (SHA: 688166), a Chinese biopharmaceutical company, has announced positive results from the Phase II clinical study (CTR20233198) for its investigational drug BGM0504. This dual agonist targets GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulin stimulating polypeptide) receptors and is being studied for the treatment of…
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Dizal Pharmaceutical’s Sunvozertinib Earns Breakthrough Designation for NSCLC from China’s NMPA
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a biopharmaceutical company based in China, has announced that it has received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib. This designation is in relation to the drug’s potential use as…
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Huawei Partners with Medical University Hospital to Boost Healthcare Innovation
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The Affiliated Hospital of Xuzhou Medical University has entered into a comprehensive partnership with Huawei Technologies Co., Ltd., a leading global provider of information and communications technology (ICT) solutions. Under this alliance, Huawei will offer a suite of advanced technologies, including network connectivity, transportation support, diverse computing power products, intelligent…
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Reforgene Medicine’s Gene Editing Therapy RM-101 Clears IND Hurdle for Usher Syndrome Treatment
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Reforgene Medicine, a pioneer in gene editing therapy based in Guangzhou, has secured Investigational New Drug (IND) approval from China’s National Medical Products Administration (NMPA) for its flagship candidate, RM-101. This AAV-based gene editing drug is aimed at treating Usher syndrome, a genetic condition that leads to significant vision impairment…
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Akeso Biopharma Secures USD 250 Million in Share Placement, Bolstering Drug Development War chest
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Akeso Biopharma (HKG: 9926), a biopharmaceutical company based in China, has declared the successful completion of a share placement that has raised USD 250 million. This capital raise has garnered significant attention from international investment firms, with a majority of the final subscribers being long-term and healthcare funds. With this…
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Jiangsu Hengrui’s RGL-193 Receives NMPA Greenlight for Parkinson’s Disease Clinical Study
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Jiangsu Hengrui Pharmaceuticals Co., Ltd, a leading pharmaceutical company based in China and listed as (SHA: 600276), has received approval from the National Medical Products Administration (NMPA) for its Category 1 drug, RGL-193. This marks a significant step forward as the drug advances into clinical studies focused on Parkinson’s disease…
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Novartis’s Brolucizumab Accepted for Review by China’s CDE for Potential DME Treatment
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The Center for Drug Evaluation (CDE) has indicated that Novartis (NYSE: NVS), the Swiss pharmaceutical giant, has had its second market filing for brolucizumab accepted for review. The filing is anticipated to be for the treatment of visual impairment resulting from macular edema associated with diabetes (DME). Brolucizumab, recognized as…
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Pfizer’s Talzenna Combo Shows Improved Survival in mCRPC Patients, According to TALAPRO-2 Study
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Pfizer Inc. (NYSE: PFE) has announced positive topline results regarding overall survival (OS) in the Phase III TALAPRO-2 study for Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, when combined with Xtandi (enzalutamide), an androgen receptor pathway inhibitor (ARPI). This combination is used for the treatment of patients with…
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Teva Pharmaceutical Reaches Settlement with DOJ Over Alleged Kickbacks and Price-Fixing
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Teva Pharmaceutical Industries Ltd (NYSE: TEVA), headquartered in Israel, has entered into a settlement agreement with the U.S. Department of Justice (DOJ) to resolve allegations of misconduct related to its multiple sclerosis (MS) therapy, Copaxone. The DOJ had filed a lawsuit in August 2020, accusing Teva of violating the Anti-Kickback…
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CSPC Pharma Initiates Phase III Trial for JMT101 in First-Line EGFR-Positive NSCLC Treatment
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has initiated a Phase III clinical study for its Category 1 drug JMT101. This study combines JMT101 with osimertinib (Tagrisso) and compares it against osimertinib alone in the first-line treatment of locally advanced or metastatic epidermal growth…
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KangaBio’s KGX101 Receives NMPA Approval for Clinical Trial in China
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KangaBio, a biopharmaceutical company based in Shanghai, has announced that its investigational new drug (IND) application for KGX101 has received clinical trial approval from the China National Medical Products Administration (NMPA). This Class 1 new drug, an IL-12 Fc fusion protein injection, is expected to be used for the treatment…
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Merck KGaA’s Pergoveris Treatment Expands Access to Advanced Reproductive Care in Greater Bay Area
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Merck KGaA (MRK, NYSE: MRK) , a leading science and technology company based in Germany, has announced the availability of its ovulation-stimulating treatment Pergoveris in the Guangdong–Hong Kong–Macao Greater Bay Area. The treatment, which combines recombinant human follicle stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH), has been approved…
