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Novartis Faces Setback in US Patent Battle Over Multiple Sclerosis Drug Gilenya
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Swiss pharmaceutical giant Novartis AG (SWX: NOVN) has encountered its latest and potentially final setback in the fight to maintain a key patent covering the multiple sclerosis drug Gilenya (fingolimod) in the United States. The company announced that the US Court of Appeals for the Federal Circuit (CAFC) had denied…
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Hengrui Medicine’s Dexmedetomidine Nasal Spray Gains Priority Review
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China’s Center for Drug Evaluation (CDE) has indicated that Hengrui Medicine Co., Ltd’s (SHA: 600276) dexmedetomidine hydrochloride nasal spray has been awarded priority review status. The drug is filed for approval as a preoperative sedation in children, such as for general anesthesia in pediatric patients. Drug Overview and Market ContextDexmedetomidine,…
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Humanwell’s Generic Clobazam Approved for Lennox-Gastaut Syndrome in China
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China-based Yichang Humanwell Pharmaceutical Co., Ltd’s generic version of Sanofi’s clobazam (trade name: Frisium) has been approved by the National Medical Products Administration (NMPA) for use as a combination therapy for seizures in patients with Lennox-Gastaut syndrome (LGS) aged two years and older. This marks the first availability of this…
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AstraZeneca and Merck’s Lynparza Receives New Approval in China
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UK-based AstraZeneca (NASDAQ: AZN) and US-based Merck, Sharp & Dohme (MSD, NYSE: MRK) have announced that they have received another indication approval from the National Medical Products Administration (NMPA) for Lynparza (olaparib). The poly (ADP-ribose) polymerase (PARP) inhibitor is now approved as a maintenance therapy for homologous recombination repair deficiency…
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Zelgen Biopharmaceuticals Gains NMPA Approval for Jacktinib Clinical Trial in SLE
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Janus kinase (JAK) inhibitor, jacktinib, in systemic lupus erythematosus (SLE). This marks a significant milestone in the development of this innovative therapy for autoimmune diseases.…
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Lepu Biotechnology’s MRG003 Receives Orphan Drug Designation from FDA
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China-based Lepu Biotechnology Co., Ltd (HKG: 2157) has announced that it has received orphan drug designation (ODD) status from the US FDA for its core product MRG003, an epidermal growth factor receptor targeted antibody drug conjugate (ADC) for the treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). Drug Mechanism and DevelopmentMRG003…
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Joincare’s Modified Drug XYP-001 Gains NMPA Approval for IPF Trial
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China-based Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its modified drug XYP-001 inhaler. The targeted indication is idiopathic pulmonary fibrosis (IPF). Disease Overview and Current TherapiesIPF is a chronic progressive fibrotic interstitial…
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CARsgen Therapeutics Presents Positive Phase Ib/II Data for CT053 at CAR-TCR Summit
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China-based CARsgen Therapeutics Holdings Ltd presented the results of a multi-center, open-label Phase Ib/II study assessing the safety and efficacy of its B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor (CAR) T cell therapy CT053 (zevor-cel) at the 7th CAR-TCR Annual Summit. The study is being conducted across North America, focusing…
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Junshi Biosciences’ Tuoyi Approved for First-Line NSCLC Treatment in China
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China’s Center for Drug Evaluation (CDE) has approved Junshi Biosciences’ (HKG: 1877, SHA: 688180) Tuoyi (toripalimab) as a first-line treatment for advanced non-small cell lung cancer (NSCLC) in tumors with no EGFR/ALK mutations, in combination with chemotherapy. This marks the sixth indication approval for the programmed death-1 (PD-1) inhibitor in…
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Sun-Novo’s STC007 Gains NMPA Approval for Postoperative Pain Study
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China-based Beijing Sun-Novo Pharmaceutical Research Co., Ltd has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study assessing its Category 1 drug candidate STC007 for postoperative pain. This marks a significant milestone in the development of this innovative therapy. Drug Mechanism…
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Tasly Pharmaceuticals Gains NMPA Approval for B1344 Diabetes Study
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China-based Tasly Pharmaceuticals (SHA: 600535) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its recombinant human fibroblast growth factor 21 injection B1344 in patients with type 2 diabetes. This marks a significant step in the development of this…
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Clover Biopharmaceuticals Reports Positive Phase III Data for COVID-19 Vaccine SCB-2019
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China-based Clover Biopharmaceuticals Ltd (HKG: 2197) has announced additional positive Phase III clinical trial data for its lead COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum), as a universal booster shot. The data show that subjects who received SCB-2019 as the third booster, following two doses of inactivated vaccine, exhibited higher levels…
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RemeGen Announces Positive Phase III Results for Telitacicept in SLE
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China-based pharma firm RemeGen (HKG: 9995) has announced the conclusion of a Phase III confirmatory study for its fusion protein drug telitacicept in systemic lupus erythematosus (SLE) in China, releasing preliminary data. The study enrolled 335 patients, randomized to receive telitacicept (160mg) or placebo via subcutaneous injection once per week…
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BeiGene’s Brukinsa Receives New EU and UK Indications for BTK Inhibitor
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China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has received two new indication recommendations in the EU and the United Kingdom for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib). The approvals expand the therapeutic applications of this innovative treatment, further solidifying its position in the global oncology…
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Alphamab Oncology Doses First Patient in Phase I Study for JSKN003 in Australia
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Alphamab Oncology (HKG: 9966) has announced that the first patient has been dosed in a Phase I clinical study for its JSKN003-KN026 antibody drug conjugate (ADC) in Australia. The open, multi-center, dosage escalation Phase I study is designed to assess the safety, tolerability, and preliminary efficacy of JSKN003 in advanced…
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Daehwa Pharmaceutical Files NDA for Liporaxel in China for Gastric Cancer Treatment
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South Korea’s Daehwa Pharmaceutical (KOSDAQ: 067080) has announced the filing of a New Drug Application (NDA) in China for Liporaxel/RMX3001, its innovative oral paclitaxel formulation. The application seeks approval for Liporaxel as a secondary treatment option for patients with advanced gastric cancer. Liporaxel: An Innovative Oral FormulationLiporaxel is an oral…
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Antengene’s ATG-101 Receives Orphan Drug Designation for Pancreatic Cancer
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China-based biotech Antengene Corp., Ltd (HKG: 6996) has announced that its pipeline candidate ATG-101, a PD-L1/4-1BB bispecific antibody (BsAb), has been awarded orphan drug designation (ODD) status from the US FDA for its use in treating pancreatic cancer. This designation is expected to facilitate greater communication with the FDA and…
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Hainan’s Lecheng Zone Updates Special Drug Insurance List with Expanded Coverage
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Hainan Boao Lecheng International Medical Tourism Pilot Zone has released an updated special drug insurance list, allowing patients in the zone to access medicines not yet market-approved in China. The insurance scheme, first introduced in 2020, was the first government-guided provincial-level supplementary special drug insurance scheme in China. This year’s…
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Ascletis Completes Enrollment for HIV Functional Cure Study with PD-L1 Antibody ASC22
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China-based Ascletis Pharma Inc. (HKG: 1672) announced that the clinical study of PD-L1 antibody ASC22 (envafolimab) in combination with chidamide as a functional cure for human immunodeficiency virus (HIV) infection has completed the enrollment of 15 HIV-infected patients. The study achieved this milestone in just two months since the first…
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Transcenta’s First-in-Class Gremlin1 Antibody TST003 Receives FDA IND Clearance
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China-based Transcenta Holding Limited (HKG: 6628) announced that its TST003, a first-in-class, high affinity humanized monoclonal antibody (mAb) targeting Gremlin1, has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA). This milestone allows Transcenta to proceed with clinical trials for this novel cancer treatment. Gremlin1…
