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Eli Lilly’s Omvoh Approved by FDA for Crohn’s Disease Treatment
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US major Eli Lilly and Company (NYSE: LLY) has announced receiving marketing approval from the US FDA for its Omvoh (mirikizumab-mrkz), an interleukin-23p19 (IL-23p19) antagonist, to treat moderately to severely active Crohn’s disease in adults. This approval follows the FDA’s nod for its use as a first-in-class treatment for moderately…
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Boehringer Ingelheim’s Iclepertin Fails to Meet Phase III Study Endpoints
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German giant Boehringer Ingelheim has disclosed negative top-line results from the Phase III CONNEX study for its iclepertin, a treatment for cognitive impairment in adults with schizophrenia. The study failed to meet either primary or key secondary endpoints, indicating no statistically significant effects on cognition or functioning in patients treated…
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Telix Pharmaceuticals’ TLX591-CDx Approved in Europe via Decentralized Procedure
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Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) has announced that the marketing filing in Europe via the Decentralized Procedure (DCP) for its TLX591-CDx (Illuccix, gallium Ga 68 PSMA-11), a radionuclide-drug conjugate (RDC) for the diagnosis of prostate cancer, has been approved by the regulatory body in the region. This approval marks…
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Daiichi Sankyo Acquires Gatipotuzumab IP Rights for $132.5M
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Japan-based Daiichi Sankyo Company, Ltd (TYO: 4568) has announced an investment of USD 132.5 million to acquire the intellectual property (IP) rights of gatipotuzumab, an antitumor-associated mucin-1 (TA-MUC1) antibody, from Germany-headquartered Glycotope GmbH. This strategic acquisition strengthens Daiichi Sankyo’s portfolio in cancer therapy. Acquisition Details and BackgroundDaiichi Sankyo obtained global…
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Impact Therapeutics’ Senaparib Cleared by NMPA for Ovarian Cancer Therapy
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China-based Impact Therapeutics has announced receiving marketing clearance from the National Medical Products Administration (NMPA) for its senaparib to be used as maintenance therapy in adult patients with advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. The clearance is for patients who have achieved complete or partial…
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SciClone and Menarini Submit NDA for Vaborem in China
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China-based SciClone Pharmaceuticals Inc and its Italy-based strategic partner Menarini have announced the submission of a New Drug Application (NDA) for Vaborem (meropenem vaborbactam) to the National Medical Products Administration (NMPA). The sought-after indication is complex urinary tract infections, including pyelonephritis. This submission marks a significant step in making this…
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Asieris’ USP1 Inhibitor APL-2302 Cleared for Clinical Trials
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China-based urogenital cancer specialist Asieris Pharmaceuticals (SHA: 688176) has announced receiving clinical clearance from the National Medical Products Administration (NMPA) for its APL-2302 (ASN-3186) in advanced solid tumors. This clearance marks a significant step forward in the development of innovative treatments for patients with advanced cancer. APL-2302: Mechanism of ActionAPL-2302…
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Zhejiang Huahai’s HB0056 Approved for US Phase I Asthma Trial
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced receiving clinical trial approval from the US Food and Drug Administration (FDA) for its HB0056. This injectable bispecific antibody (BsAb) targets thymic stromal lymphopoietin (TSLP) and interleukin-11 (IL-11) and is now cleared to enter Phase I clinical study in asthma.…
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Hengrui’s HER2-Targeted ADC and Antibody Drug Combo Approved for Trials
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its SHR-A1811 combined with SHR-9839 in advanced solid tumors. This approval is a significant step forward in the development of innovative treatments for patients with advanced cancer. SHR-A1811:…
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CSPC’s SYS 6043 Receives FDA Approval for Clinical Trials
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its in-house developed SYS 6043 has obtained clinical trial approval from the US Food and Drug Administration (FDA). This approval marks a significant step forward in the development of innovative treatments for advanced/metastatic solid tumors. Clinical Trial Scope and ObjectivesThe…
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Innovent’s Limertinib Wins NMPA Approval for NSCLC Treatment
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced that it has received New Drug Application (NDA) approval from the National Medical Products Administration (NMPA) for its limertinib. This third-generation EGFR TKI has been approved for use in adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer…
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HutchMed’s Orpathys Approved for Expanded NSCLC Indication in China
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HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) has announced that the National Medical Products Administration (NMPA) has approved another indication for its Orpathys (savolitinib). This approval means that the MET inhibitor can now be used to treat adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with…
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Innovent’s IBI343 Receives Breakthrough Therapy Designation for Pancreatic Cancer
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China-based biopharma Innovent Biologics, Inc. (HKG: 1801) has announced receiving another Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its IBI343. The latest designation was granted for the TOPO1i anti-CLDN18.2 antibody drug conjugate (ADC) as monotherapy for the treatment…
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Wepon Medical’s WP107 Receives FDA Approval for gMG Clinical Trial
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China-based Wepon Medical Holding Group Co., Ltd. (SHE: 002082) has announced receiving clinical trial approval from the US Food and Drug Administration (FDA) for its in-house developed WP107 (huperzine A). The acetylcholinesterase inhibitor is slated to enter a clinical study for the treatment of generalized myasthenia gravis (gMG). WP107: Preclinical…
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Fosun Pharma Initiates Phase II Study for Glomerular Disease Treatment
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced the initiation of a Phase II study for its Category I chemical drug, XH-S003, in glomerular diseases related to abnormal complement activation, such as IgA nephropathy in China. This marks a significant step forward in the development of…
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Hengrui’s SHR-9839 Receives NMPA Clearance for Advanced Tumors
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving clinical clearance from the National Medical Products Administration (NMPA) for its SHR-9839 subcutaneous (SC) injection in advanced solid tumors. This clearance marks a significant step forward in the development of innovative treatments for patients with advanced malignant tumors. SHR-9839:…
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Chongqing Genrix’s Silevimig NDA Accepted for Rabies Immunization Review
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China-based Chongqing Genrix Bio Pharmaceutical Co., Ltd. (SHA: 688443) has announced that a New Drug Application (NDA) filing for its silevimig (GR1801) has been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The drug is intended for passive immunization in adults…
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Hengrui and Kailera Announce Positive Phase II Results for HRS9531 in Weight Loss
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) and its US partner Kailera Therapeutics, Inc. have jointly announced positive results from a Phase II weight loss study for HRS9531, a GLP-1/GIP receptor dual agonist. The study evaluated the drug at an 8 mg dose, which achieved significant weight loss and…
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Leqembi Autoinjector Advances with FDA Review for Alzheimer’s Treatment
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Partners Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have announced that the US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for Leqembi (lecanemab) subcutaneous autoinjector (SC-AI) for review. The application seeks approval for the treatment of Alzheimer’s disease (AD) in patients with…
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Novo Nordisk Launches Rybelsus in China, World’s First Oral GLP-1RA
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Denmark-based pharmaceutical giant Novo Nordisk (NYSE: NVO) has announced the commercial launch of its innovative diabetes treatment, Rybelsus (semaglutide), in China. This marks a significant milestone for the company as it expands its presence in the Chinese market. Rybelsus: A First-in-Class TherapyRybelsus holds the distinction of being the world’s first…
