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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,…
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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 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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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…
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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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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…