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China-based Hua Medicine (HKG: 2552) has announced the termination of its co-promotion agreement with German pharmaceutical giant Bayer AG (ETR: BAYN) regarding HuaTangNing (dorzagliatin tablets, HMS5552), effective January 1, 2025. The agreement, which began in August 2020, focused on the promotion and distribution of the drug in China. Dorzagliatin’s Impact…
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Shanghai-based United Imaging Healthcare Co., Ltd. has announced the installation of an ultra-wide-bore AI-empowered uMR OMEGA at XRANM’s Breast Health & Imaging Center in New Mexico, United States. This cutting-edge installation marks a significant advancement in patient care and comfort in the field of medical imaging. The uMR OMEGA: Combining…
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China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced the submission of a New Drug Application (NDA) to the National Medical Products Administration (NMPA) for its combination therapy of anlotinib and penpulimab in first-line advanced hepatocellular carcinoma (HCC). Phase III Study Data Supports NDA FilingThe filing is supported by data from…
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China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced an exclusive licensing agreement between its subsidiary Huisheng Pharm and MEIYOUNG. The deal pertains to Huisheng’s biosimilar version of Denmark-based Novo Nordisk’s (NYSE: NVO) weight loss drug semaglutide (Ozempic/Wegovy) for the treatment of overweight or obesity in China. Terms of…
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The Center for Drug Evaluation (CDE) website has indicated that China-based Innovent Biologics, Inc. (HKG: 1801) is set to obtain breakthrough therapy designation (BTD) for its antibody drug conjugate (ADC) IBI354, which targets HER2, for the treatment of platinum-resistant ovarian cancer. Phase I/II Clinical Study ResultsThe Phase I/II clinical study…
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China’s Center for Drug Evaluation (CDE) has announced the inclusion of China Resources Double-Crane Pharmaceutical Co., Ltd’s (SHA: 600062) hydroxocobalamine and Sanofi (NASDAQ: SNY) Genzyme’s fitusiran in its patient-centered rare disease drug development pilot program, known as the Care Plan. Hydroxocobalamine for Metabolic Disorders in Children with MMAHydroxocobalamine, also referred…
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Apeiron Therapeutics, a biomarker-driven cancer therapy developer with operations in Shanghai, China, and San Francisco, US, has announced the enrollment of the first patient in the Phase Ia/B study for its investigational drug GTA182. The dosage escalation study aims to assess the safety, efficacy, and pharmacokinetics of the small molecule…
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German pharmaceutical major Boehringer Ingelheim (BI) has entered into a partnership with China-based Sinopharm Group Co., Ltd (HKG: 1099), granting the latter the rights to promote Boehringer Ingelheim’s Sifrol (pramipexole) and Pradaxa (dabigatran) in China effective from January 1, 2025. Boehringer Ingelheim will retain ownership and manufacturing responsibilities for both…
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US-Irish firm Medtronic (NYSE: MDT) has announced US market approval for its new InPen app, which features missed meal dose detection. This innovation marks a significant step in the launch of Medtronic’s Smart MDI system, integrated with the Simplera continuous glucose monitor (CGM). InPen App: A Pioneer in Real-Time Insulin…
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China-based CStone Pharmaceuticals (HKG: 2616) has announced a strategic commercial collaboration with Pharmalink Store – L.L.C – O.P.C (Pharmalink), a prominent pharmaceutical company based in the United Arab Emirates (UAE), concerning its anti-PD-L1 monoclonal antibody (mAb) sugemalimab. Commercial Rights and Deal TermsUnder the agreement, Pharmalink will acquire the commercial rights…
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The National Medical Products Administration (NMPA) has granted approval to China-based Alpha Biopharma’s zorifertinib, commercially known as Zorifer, for the treatment of first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation and central nervous…
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US pharmaceutical major Pfizer Inc. (NYSE: PFE) has announced that the European Commission (EC) has granted approval for its drug Hympavzi (marstacimab-hncq) for the routine prophylaxis of bleeding episodes in patients aged 12 years and older weighing at least 35 kg with severe hemophilia A (congenital factor VIII [FVIII] deficiency,…
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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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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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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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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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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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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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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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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…