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Lepu Biopharma Licenses Potential Best-in-Class ADC MRG007 to ArriVent
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Lepu Biopharma Co., Ltd (HKG: 2157) has announced an exclusive licensing agreement with ArriVent BioPharma, Inc. (NASDAQ: AVBP) for MRG007, a potential best-in-class antibody-drug conjugate (ADC) targeting gastrointestinal (GI) cancers. This partnership aims to advance the development and commercialization of MRG007 globally, excluding Greater China. Agreement DetailsUnder the terms of…
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Keymed and InnoCare Announce Licensing Deal for CD20xCD3 Bispecific Antibody with Prolium
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China-based Keymed Biosciences Inc. (HKG: 2162) and InnoCare Pharma (HKG: 9969, SHA: 688428) have jointly announced a licensing agreement with Prolium, a US-based biotech backed by RTW Investments. Under the terms of the agreement, Prolium will obtain development, regulatory filing, manufacturing, and commercialization rights to ICP-B02 (CM355), a CD20xCD3 bispecific…
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Kelun-Biotech’s Tagitanlimab Receives NMPA Clearance for Nasopharyngeal Carcinoma
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced receiving another clearance from the National Medical Products Administration (NMPA) for its PD-L1 monoclonal antibody (mAb) Ketailai (tagitanlimab). The latest approval indicates the drug for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) when combined with chemotherapy. This follows…
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Junshi Biosciences Licenses Toripalimab to LEO Pharma for EU and UK Markets
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China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced a licensing agreement with Denmark-based LEO Pharma A/S, granting the dermatology specialist exclusive rights to store, distribute, promote, market, and sell its PD-1 inhibitor, toripalimab, in the European Union (EU), the European Economic Area (EEA), Switzerland, and the…
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FDA Approves AstraZeneca’s Calquence for Mantle Cell Lymphoma
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UK-based pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) last week revealed that the US Food and Drug Administration (FDA) has approved its BTK inhibitor Calquence (acalabrutinib) in combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic…
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FDA Clears Amgen’s Lumakras and Vectibix Combo for KRAS G12C-mutated mCRC
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US-based Amgen (NASDAQ: AMGN) has announced receiving clearance from the US Food and Drug Administration (FDA) for its Lumakras (sotorasib) combined with Vectibix (panitumumab) for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC). This approval is for patients whose cancer has been identified through an FDA-approved…
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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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Junshi Biosciences’ Toripalimab Gains TGA Approval for Nasopharyngeal Carcinoma
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China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced receiving marketing approval from the Therapeutic Goods Administration (TGA) of the Australian Government Department of Health and Aged Care for its toripalimab. The anti-PD-1 monoclonal antibody can now be used in combination with cisplatin and gemcitabine for the…
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Aosaikang’s Limertinib Approved for EGFR T790M-Mutated NSCLC
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Jiangsu Aosaikang Pharmaceutical Co., Ltd (ASK Pharm, SHE: 002755) has recently received approval from the National Medical Products Administration (NMPA) for the registration and market launch of its drug Limertinib (Brand name: Aoyixing). The drug is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell…
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Johnson & Johnson Submits NDA for TAR-200 in High-Risk Bladder Cancer
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US-based Johnson & Johnson (J&J, NYSE: JNJ) has announced the initiation of the submission of a New Drug Application (NDA) filing with the US Food and Drug Administration (FDA) for TAR-200. The drug is intended for use in patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma…
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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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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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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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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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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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Chipscreen’s Epidaza Patent Faces Invalidation Request Review
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China-based Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321) has announced that a patent invalidation request filed by compatriot firm Chia Tai Tianqing relating to its Epidaza (chidamide) has been accepted for review by the China National Intellectual Property Administration (CNIPA). This development marks a significant legal milestone in the protection…
