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Merck KGaA Partners with Roche to Commercialize Tepmetko in China
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Germany-based pharmaceutical giant Merck KGaA (ETR: MRK) has entered into a partnership with Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY) to commercialize its lung cancer targeted drug Tepmetko (tepotinib) in mainland China. This collaboration aims to leverage the strengths of both companies to bring Tepmetko to more patients in need.…
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Jiangsu Hengrui Pharmaceuticals’ Ivarmacitinib Receives NMPA Approval for Ankylosing Spondylitis
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its JAK1 inhibitor ivarmacitinib. The drug is now approved for use in treating adult patients with active ankylosing spondylitis (AS) who have had poor efficacy or intolerance to one or…
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HutchMed and Innovent Announce Positive Results for Fruquintinib and Sintilimab in Renal Cell Carcinoma Trial
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Chinese companies HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) and Innovent Biologics, Inc. (HKG: 1801) jointly announced positive results from the Phase II/III FRUSICA-2 study. The trial evaluated the combination of fruquintinib and sintilimab as a second-line treatment for locally advanced or metastatic renal cell carcinoma (RCC) in China, with…
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Hansoh Pharmaceutical’s Ameile Wins New NMPA Approval for Advanced NSCLC Treatment
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Ameile (almonertinib). The epidermal growth factor receptor (EGFR) inhibitor is now approved to treat unresectable locally advanced EGFR exon 19 deletion or exon 21 (L858R) replacement mutation-positive non-small…
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TYK Medicines Inc.’s TY-9591 Shows Superiority Over Osimertinib in EGFR Mutated Lung Cancer with Brain Metastasis
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Zhejiang-based TYK Medicines Inc. (HKG: 2410) announced positive results from a pivotal Phase II study positioning TY-9591 against osimertinib as a first-line treatment for epidermal growth factor receptor (EGFR) mutated lung cancer with brain metastasis. The data demonstrated statistical significance and significant clinical benefits, marking a potential breakthrough in the…
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Zai Lab’s Augtyro Receives TFDA Approval for ROS1-Positive NSCLC and NTRK Fusion Solid Tumors
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China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced that it has received marketing approval from the Taiwan Food and Drug Administration (TFDA) for its Augtyro (repotrectinib). The drug is approved for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC) and adult…
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Hansoh Pharmaceutical’s HS-10561 Receives NMPA Clearance for Chronic Spontaneous Urticaria
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 drug HS-10561, a Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of chronic spontaneous urticaria (CSU). Licensing AgreementHS-10561 was licensed from fellow Chinese…
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InnoCare Pharma Receives NMPA Approval for Mesutoclax Phase III Study in CLL/SLL
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Beijing-based biotech InnoCare Pharma (HKG: 9969, SHA: 688428) announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a regulatory Phase III clinical study for its B-cell lymphoma-2 (BCL2) inhibitor mesutoclax (ICP-248) in combination with its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib. The study will…
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Hengrui Pharma Submits Ivarmacitinib Ointment for AD Treatment Approval
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced the submission of a marketing filing for its ivarmacitinib ointment to the National Medical Products Administration (NMPA). The Chinese company is seeking approval for the drug’s use as a topical treatment for mild to moderate atopic dermatitis (AD) in adults. Drug ProfileIvarmarcitinib…
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Betta Pharma Files for EMA Approval of ALK Inhibitor Ensartinib
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Betta Pharmaceuticals (SHE: 300558) announced the initiation of a market approval filing with the European Medicines Agency (EMA) for its anaplastic lymphoma kinase (ALK) inhibitor, ensartinib. The drug is under co-development with Betta affiliate Xcovery. The Chinese firm is seeking EMA approval for the drug’s use as a first-line treatment…
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Allist Pharmaceuticals Gains NMPA Approval for Furmonertinib Clinical Study
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Shanghai-based biotech Allist Pharmaceuticals Co., Ltd has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study assessing its furmonertinib as an adjuvant therapy for stage IB-IIIB non-small cell lung cancer (NSCLC) carrying non-classical epidermal growth factor receptor (EGFR) mutations. The study will evaluate the…
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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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NMPA Approves J&J’s FGFR Kinase Inhibitor Balversa for Urothelial Carcinoma
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China’s National Medical Products Administration (NMPA) has approved Johnson & Johnson’s (J&J; NYSE: JNJ) FGFR kinase inhibitor Balversa (erdafitinib) for the treatment of adult patients with unresectable locally advanced or metastatic urothelial carcinoma (UC). The drug is indicated for patients who carry susceptible FGFR3 gene mutations and have undergone at…
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HutchMed’s Orpathys Receives Priority Review for NSCLC Treatment in China
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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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Nuvation Bio’s Taletrectinib NDA for ROS1+ NSCLC Receives FDA Priority Review
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US-based Nuvation Bio Inc. (NYSE: NUVB) has announced that the New Drug Application (NDA) for its investigational next-generation ROS1 tyrosine kinase inhibitor (TKI), taletrectinib, has been accepted for review by the US Food and Drug Administration (FDA) with priority review status. The filing seeks approval for taletrectinib to treat advanced…
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Innovent Biologics’ Taletrectinib Wins NMPA Approval for ROS1+ NSCLC Treatment
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its taletrectinib, a second-generation ROS1 tyrosine kinase inhibitor. The drug is now approved for use in treating adult patients with ROS1 positive locally advanced or metastatic non-small cell lung cancer (NSCLC)…
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FDA Approves Xcovery Holdings’ Ensartinib for Untreated ALK-Positive NSCLC Patients
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On December 18, 2024, the Food and Drug Administration (FDA) granted approval for Betta Pharmaceutical (SHE: 300558) and its controlling subsidiary Xcovery Holdings, Inc.’s ensartinib (Ensacove), a treatment for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received…
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Innovent Biologics Partners with Eli Lilly for Distribution of Jaypirca in China
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China-based Innovent Biologics, Inc. (HKG: 1801) has entered into a significant distribution and promotion agreement with US pharmaceutical giant Eli Lilly and Company (NYSE: LLY). The agreement pertains to Lilly’s non-covalent Bruton’s tyrosine kinase (BTK) inhibitor, Jaypirca (pirtobrutinib). Financial details of the agreement have not been disclosed. Under the terms,…
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HutchMed to Receive Milestone Payment as Takeda’s Fruzaqla Gets Reimbursement Nod in Spain
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China-based HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) is poised to receive another milestone payment from its partner Takeda (TYO: 4502, NYSE:TAK), following the Japanese firm’s achievement of a national reimbursement recommendation for Fruzaqla (fruquintinib) for patients with previously treated metastatic colorectal cancer (CRC) in Spain. This event marks the…
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HutchMed and Innovent Biologics’ Fruzaqla-Tyvyt Combo Gets NMPA Conditional Approval for Endometrial Cancer
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Chinese firms HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) and Innovent Biologics, Inc. (HKG: 1801) have jointly announced that they have received conditional approval from the National Medical Products Administration (NMPA) for the combination of Fruzaqla (fruquintinib) and Tyvyt (sintilimab). This treatment is intended for patients with advanced endometrial cancer…
