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US pharmaceutical major Eli Lilly & Co. (NYSE: LLY) has announced the official market launch of its drug Mounjaro (tirzepatide) in China, expanding access to this treatment for patients in the region. Coverage of Two IndicationsThe launch of Mounjaro in China covers two specific indications. The first is for the…
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China’s Shanghai Pharmaceuticals (SPH, HKG: 2607, SHA: 601607) has declared the termination of clinical trials and subsequent development of I001-B (US), I022 (US), and C012 (US). This decision comes after a comprehensive evaluation of the future market value, business collaboration, and development investment required for these projects. I001-B and I022…
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China’s National Medical Products Administration (NMPA) has indicated on its website that Japan-based Astellas Pharma Inc. (TYO: 4503) has received approval for its drug Vyloy (zolbetuximab-clzb). The drug is approved for use in combination with fluoropyrimidine- and platinum-containing chemotherapy for first-line locally advanced unresectable or metastatic claudin (CLDN) 18.2 positive,…
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its programmed death ligand 1 (PD-L1) monoclonal antibody (mAb), Ketailai (KL-A167). This treatment is now approved for use in recurrent or metastatic nasopharyngeal carcinoma (NPC) patients…
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HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) has announced that the China National Medical Products Administration (NMPA) has accepted and granted priority review to the New Drug Application (NDA) for its Orpathys (savolitinib). The Chinese company is seeking approval for its MET tyrosine kinase inhibitor (TKI), when combined with Tagrisso…
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China-based Lee’s Pharmaceutical Holdings Ltd’s (HKG: 0950) former subsidiary, Zhaoke Ophthalmology Ltd (HKG: 6622), has announced positive topline results from the Phase III study for its core candidate drug TAB014 in the treatment of wet (neovascularization) age-related macular degeneration (wAMD). The study successfully met all primary and key secondary endpoints,…
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China-based Alphamab Oncology (HKG: 9966) has announced that it has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to proceed with a Phase III study for its drug candidate JSKN033. The study will compare JSKN033 against the investigator’s choice of chemotherapy in…
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Sino-US firm Frontera Therapeutics, Inc. has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase II study assessing its recombinant adeno-associated virus (rAAV) gene therapy, FT-003, in patients with diabetic macular edema (DME). This follows previous clearance for a Phase II…
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US healthcare giant Johnson & Johnson (J&J, NYSE: JNJ) has announced that the European Commission (EC) has granted label extension approval for its Rybrevant (amivantamab) combined with Lazcluze (lazertinib) for the treatment of first-line advanced non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 19 deletions…
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced positive topline results from the Phase III STEER study, which was designed to assess the efficacy and safety of its intrathecal onasemnogene abeparvovec (OAV101 IT) in treatment-naïve patients with spinal muscular atrophy (SMA) Type 2. The study focused on patients aged two…
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The national Volume-Based Procurement (VBP) authorities have released comprehensive details regarding the 10th VBP round, including volumes and regions awarded to winning bidders. According to Fineline Info & Tech‘s calculations, the full round, covering 196 companies with winning bids, was valued at over RMB1.3 billion (USD 178 million) in contracts.…
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China-based Jiangxi Jemincare Group has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) to test its Category 2.2 modified drug, JMX-2006, in prostate cancer. JMX-2006: An Innovative Sustain-Released Preparation for Prostate CancerJMX-2006 is an innovative sustain-released preparation designed to offer less frequent dosages,…
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced the initiation of an investigator-initiated-trial (ITT) for its chimeric antigen receptor (CAR)-T therapy candidate product, KJ-C2219, in China. The trial is aimed at treating recurrent/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). KJ-C2219: A Universal CAR-T Therapy Targeting CD19 and CD20KJ-C2219 is a…
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Chengdu-based biotech Hinova Pharmaceuticals Inc., (SHA: 688302) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its drug candidate, HP568. The Chinese firm plans to test HP568 in patients with estrogen receptor (ER) positive, human epidermal growth factor receptor 2 negative…
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China-based CanSino Biologics (HKG: 6185) has received market approval from the Badan Pengawas Obat dan Makanan (BPOM) of Indonesia for its ACYW135 Meningococcal Conjugate Vaccine (CRM197), commercially known as Menhycia. Menhycia: Protection for Infants and Young ChildrenMenhycia is indicated for infants and young children aged between 3 months to 3…
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its GnRH receptor agonist, SYH9016, in the treatment of solid tumors. SYH9016: A Modified Leuprorelin Product for Solid TumorsSYH9016 is a novel modified…
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Sino-US firm MicuRx Pharmaceuticals Inc. has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its in-house developed antibiotic, MRX-5, for the treatment of non-tuberculosis Mycobacterium (NTM) infections. MRX-5: A Promising New Antibiotic for NTMMRX-5 is a novel benzodiazole antibiotic specifically designed to…
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced positive results from its pivotal Phase II CT041-ST-01 study for satricabtagene autoleucel, a chimeric antigen receptor (CAR) T-cell therapy. The study, which is randomized, controlled, and multi-center, aims to evaluate the efficacy and safety of the therapy in patients with CLDN18.2-expressing…
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Holland-based argenx SE (NASDAQ: ARGX) has announced receiving another indication approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). This approval allows the drug to be used for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP), who can…
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Japan-based pharmaceutical company Daiichi Sankyo (TYO: 4568) has announced that it has received marketing approval in Japan for its datopotamab deruxtecan, to be sold under the commercial name Datroway. Datroway is indicated for the treatment of adult patients with hormone receptor (HR) positive, HER2 negative unresectable or recurrent breast cancer,…