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Guangdong Zhongsheng Pharmaceutical’s RAY1225 Shows Positive Results in Phase II Study
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Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), a China-based pharmaceutical company, has announced positive top-line results from Part A of a Phase II clinical study for its Category 1 innovative polypeptide drug candidate, RAY1225. The drug demonstrated significant superiority over placebo in achieving weight loss targets and alleviating multiple cardiovascular…
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Shenzhen Chipscreen Biosciences Announces Private Placement to Fund Drug R&D and Expansion
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China-based biopharmaceutical company Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321) has announced plans for a private placement of 122,000,000 shares, valued at RMB 960 billion (USD 133 million). This strategic move aims to bolster the company’s financial position and support its research and development (R&D) initiatives. Investment in In-House Drug…
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US FDA Grants ODD to Ractigen’s siRNA Therapy RAG-21 for ALS Treatment
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China-based small activating RNA (saRNA) drug developer, Ractigen Therapeutics, has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its drug candidate RAG-21. This FUS gene-targeted siRNA therapy is indicated for the treatment of amyotrophic lateral sclerosis (ALS), an incurable and…
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UCB’s Bimzelx Receives US FDA Approval for Moderate to Severe Hidradenitis Suppurativa
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Belgium-based biopharmaceutical company UCB (FRA: UNC) has announced that the US Food and Drug Administration (FDA) has granted another indication approval for its drug Bimzelx (bimekizumab), an interleukin 17A (IL-17A) and IL-17F targeted antibody. The FDA has approved Bimzelx for the treatment of adults with moderate to severe hidradenitis suppurativa…
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Alloy Therapeutics Partners with Takeda on iPSC-Derived CAR-T and CAR-NK Therapies
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US-based Alloy Therapeutics Inc. has announced a strategic partnership with Japan-headquartered Takeda Pharmaceutical Co., Ltd (TYO: 4502) to develop Takeda’s proprietary induced pluripotent stem cell (iPSC) derived CAR-T cell platform (iCAR-T) and iPSC-derived CAR-NK platform (iCAR-NK). This collaboration aims to bolster the development of key therapies targeting solid and hematological…
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Laekna and Eli Lilly & Co. Enter Clinical Cooperation to Advance Obesity Treatment LAE102
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Sino-US biotech company Laekna, Inc. (HKG: 2105) has announced a significant clinical cooperation agreement with US pharmaceutical major Eli Lilly & Co., (NYSE: LLY), aimed at accelerating the global clinical development of Laekna’s obesity treatment candidate, LAE102. Under the terms of the agreement, Lilly will take on the responsibility for…
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GSK’s Linerixibat Demonstrates Efficacy in Phase III GLISTEN Study for Cholestatic Pruritus
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UK-based pharmaceutical giant GlaxoSmithKline (GSK; NYSE: GSK) has announced positive headline results from the Phase III GLISTEN study, which assessed the efficacy of its ileal bile acid transporter (IBAT) inhibitor, linerixibat, in treating cholestatic pruritus (relentless itch) associated with primary biliary cholangitis (PBC). Study Design and Primary Endpoint AchievementThe GLISTEN…
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Astellas Pharma’s Izervay sNDA for Geographic Atrophy Receives FDA Complete Response Letter
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Japan-based Astellas Pharma Inc. (TYO: 4568) has announced that its supplemental New Drug Application (sNDA) for Izervay (avacincaptad pegol), indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), has received a Complete Response Letter (CRL) from the US FDA. The CRL addresses a statistical matter…
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Bayer AG Secures Exclusive Rights to Cytokinetics’ Aficamten in Japan
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Germany-based Bayer AG (ETR: BAYN) has announced a significant collaboration and license agreement with US-based Cytokinetics, Incorporated (NASDAQ: CYTK), acquiring exclusive development and commercialization rights to aficamten in Japan. The agreement is subject to certain reserved development rights of Cytokinetics. Phase III Study and Global Trial ExpansionUnder the terms of…
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MSD Announces Positive Topline Results from Phase III Subcutaneous Keytruda Trial
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US-based Merck, Sharp & Dohme Inc., (MSD, NYSE: MRK) has released positive topline results from the pivotal Phase III MK-3475A-D77 trial. The study aimed to assess the noninferiority of subcutaneous administration of PD-1 inhibitor Keytruda (pembrolizumab) combined with berahyaluronidase alfa, a hyaluronidase variant developed by Alteogen Inc., in comparison to…
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Servier and Dana-Farber Launch SHINEDoc Program, Enroll First PhD Student
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French pharmaceutical company Servier and the US-based Dana-Farber Cancer Institute have announced the start of the Servier-funded SHINEDoc program in the United States, with the enrollment of the first PhD student from Dana-Farber. The program, which is set to begin this month, marks a significant step in fostering innovation in…
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New Horizon Health Registers Three Medical Devices in Hong Kong’s Department of Health
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Hangzhou-based New Horizon Health Ltd (HKG: 6606) has announced the successful registration of three of its medical products with the Department of Health in the Hong Kong Special Administrative Region, facilitated through the Medical Device Administrative Control System (MDACS). This development marks a significant expansion of the company’s reach and…
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Brii Biosciences’ Elebsiran Shows Promising Results in Phase II ENSURE Study for Chronic HBV
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China-based Brii Biosciences Ltd (HKG: 2137) has published the latest data from its ongoing Phase II ENSURE study for elebsiran (BRII-835, VIR-2218), an investigational small interfering ribonucleic acid (siRNA) therapy for chronic hepatitis B virus (HBV) infection. Phase II ENSURE Study Design and Initial FindingsThe active-controlled and randomized Phase II…
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Epigenic Therapeutics Receives Approval for EPI-003 Clinical Study in New Zealand
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Shanghai-based Epigenic Therapeutics, a biotechnology company specializing in the development of novel gene modulation therapies, has announced that it has received approval from the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) and The Health and Disability Ethics Committees (HDEC) to conduct a clinical study for its investigational drug,…
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UCB and Biogen’s Dapirolizumab Pegol Shows Promise in Phase III SLE Study
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Partners UCB (FRA: UNC) and Biogen Inc. (NASDAQ: BIIB) have announced positive results from a Phase III study of their co-developed drug candidate, dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L agent, when combined with the standard-of-care (SOC) in patients with moderate-to-severe systemic lupus erythematosus (SLE). The findings, which indicate a…
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Beijing Balance Medical Technology’s ePTFE Implant Accepted for NMPA Review
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Beijing Balance Medical Technology Co., Ltd (SHA: 688198) has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for an expanded polytetrafluoroethylene (ePTFE) implant. This Category III medical device is specifically processed and manufactured for the repair or reconstruction of the pericardium during cardiac surgery.…
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Betta Pharmaceuticals’ MCLA-129 Approved for Clinical Trial in Advanced Solid Tumors
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China’s Betta Pharmaceuticals (SHE: 300558) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 drug candidate, MCLA-129. The upcoming trial will evaluate the biologic product as a potential treatment for advanced solid tumors, including wild-type colorectal cancer, liver cancer,…
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Hangzhou Jiuyuan Gene Engineering Plans HKEX IPO to Raise Up to USD 73.2 Million
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Hangzhou Jiuyuan Gene Engineering Co., Ltd. is poised to conduct an initial public offering (IPO) of 45,398,800 shares on the Hong Kong Stock Exchange (HKEX) on November 26, following the receipt of approval from the exchange earlier this week. The company has priced each share at 12.56, aiming to raise…
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Shanghai Junshi Biosciences Enters Licensing Agreement for Dual-Targeted Fusion Proteins
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a China-based biopharmaceutical company, has announced a licensing agreement with an undisclosed company due to commercial sensitivity and trade secret considerations. Exclusive Licensing Rights for Greater ChinaAccording to the agreement, Junshi Bio will secure exclusive licensing rights and sublicensing rights to…
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Biogen and Samsung Bioepis Win EC Approval for Opuviz Biosimilar in Europe
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US-based Biogen Inc. (NASDAQ: BIIB) and South Korea’s Samsung Bioepis Co., Ltd. have jointly announced that they have received marketing approval from the European Commission (EC) for their Opuviz 40 mg/mL solution for injection in a vial. This biosimilar product, a version of Bayer/Regeneron’s Eylea (aflibercept), is now approved for…
