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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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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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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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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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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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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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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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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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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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Chengdu-based Easton Pharmaceutical Co., Ltd (SHA: 688513) has announced that it has received separate marketing approvals from the National Medical Products Administration (NMPA) for its generic versions of Incyte Corporation’s Jakavi(ruxolitinib) and Missionpharma’s Urocit-K(potassium citrate), marking a significant milestone for the company. Approval of Generic JakaviJakavi, a JAK inhibitor, is…
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Shenzhen-based Innorna Co., Ltd, a leading platform company specializing in mRNA technology and LNP (lipid nanoparticle) delivery technology, has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its investigational mRNA drug, IN015. The designation is for the treatment of progressive…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its investigational drug HRS-6208 as a monotherapy for solid tumors. HRS-6208: A Selective Small Molecule InhibitorThe drug, a selective small molecule inhibitor with…
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China-based InxMed (Nanjing) Co., Ltd has announced that the Center for Drug Evaluation of the National Medical Products Administration (NMPA) has granted a Breakthrough Therapy Designation (BTD) to its innovative small-molecule ifebemtinib (IN10018). The designation is for the use of ifebemtinib, a focal adhesion kinase (FAK) inhibitor, in combination with…
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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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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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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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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,…