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MediLink’s YL201 Receives Breakthrough Therapy Designation for Nasopharyngeal Carcinoma
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Suzhou-based biotech MediLink Therapeutics (Suzhou) Co., Ltd has announced receiving another breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC) YL201. The designation is for the treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC), following the…
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Jiangsu Lianhuan Completes Enrollment for Phase III Study of LH-1801 in Type 2 Diabetes
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China-based Jiangsu Lianhuan Pharmaceutical Co., Ltd (SHA: 600513) has announced the completion of subject enrollment for the Phase III clinical study of its Category 1 drug LH-1801, in combination with metformin. The study aims to evaluate the efficacy and safety of LH-1801 in treating type 2 diabetes, building on its…
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Arrowhead’s Plozasiran Accepted for FDA Review in Familial Chylomicronemia Syndrome
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US-based Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) has announced that the New Drug Application (NDA) for its plozasiran, targeting familial chylomicronemia syndrome (FCS), has been accepted for review by the US Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) target date for the review is set for…
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GSK’s Jemperli Approved for First-Line Endometrial Cancer Treatment in EU
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UK-based GSK plc (NYSE: GSK, LON: GSK) has announced receiving approval from the European Commission for a new indication for its PD-1-blocking antibody Jemperli (dostarlimab). The drug is now approved for use in combination with chemotherapy (carboplatin and paclitaxel) as a first-line treatment for adult patients with primary advanced or…
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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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CARsgen Therapeutics Initiates Trial for Universal CAR-T Therapy KJ-C2320 in AML
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced the first subject dosing in an investigator-initiated trial (ITT) for its KJ-C2320, a universal chimeric antigen receptor (CAR)-T cell therapy targeting recurrent/refractory acute myeloid leukemia (R/R AML). This milestone marks a significant step forward in the development of innovative treatments for…
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Chongqing Genrix’s Xeligekimab Approved for Ankylosing Spondylitis by NMPA
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China-based Chongqing Genrix Bio Pharmaceutical Co., Ltd (SHA: 688443) has announced receiving approval from the National Medical Products Administration (NMPA) for an additional indication of its in-house developed Category 1 biologic product, xeligekimab. The anti-IL-17 antibody is now approved to treat ankylosing spondylitis (radiologically positive axial spondyloarthritis), following its initial…
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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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MHRA Approves Gilead’s Livdelzi for Primary Biliary Cholangitis
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The Medicines and Healthcare products Regulatory Agency (MHRA) last week signed off on US-based Gilead Sciences Inc.’s (NASDAQ: GILD) Livdelzi (seladelpar) for the treatment of primary biliary cholangitis (PBC), including pruritus. This approval marks a significant step forward in the treatment options available for patients suffering from this chronic liver…
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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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Luye Pharma Launches Erzofri in US Market
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China-based Luye Pharma Group (HKG: 2186) has announced the initiation of commercialization of its in-house developed Erzofri (paliperidone palmitate extended-release injectable suspension) in the United States, with the first batch of products already shipped. This marks a significant milestone in the company’s global expansion strategy. Erzofri: Long-Acting Injection for SchizophreniaErzofri…
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Novo Nordisk’s Semaglutide 7.2 mg Shows Superior Weight Loss in Phase III Study
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Denmark-based Novo Nordisk A/S (NYSE: NVO) has announced positive headline results from the Phase III STEP UP study, assessing the efficacy and safety of subcutaneous semaglutide 7.2 mg compared to semaglutide 2.4 mg and placebo. The study met its primary endpoint, demonstrating superior weight loss outcomes with the higher dose.…
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Zai Lab’s KarXT NDA Accepted by NMPA for Schizophrenia Treatment
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China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has announced that a New Drug Application (NDA) filing for its KarXT (xanomeline and trospium chloride) in adult schizophrenia has been accepted for review by the National Medical Products Administration (NMPA). This milestone underscores Zai Lab’s commitment to advancing innovative treatments…
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Frontier Biotechnologies Gains NMPA Approval for Albuvirtide Phase II Study
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Nanjing-based Frontier Biotechnologies Inc. has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its version of albuvirtide, China’s first domestically developed innovative HIV therapy. The study will assess the drug’s efficacy in addressing immune reconstitution insufficiency in HIV-1 infected patients…
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Wanbangde’s Huperzine A Receives FDA Clearance for HIE Study
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China’s Wanbangde New Building Materials Co., Ltd (SHE: 002082) has announced receiving clearance from the US Food and Drug Administration (FDA) to study its huperzine A in neonatal hypoxic-ischemic encephalopathy (HIE). This indication has earned the drug a rare pediatric disease (RPD) designation and orphan drug designation (ODD) from the…
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FDA Approves Datroway for HR+/HER2- Breast Cancer Treatment
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Datroway (datopotamab deruxtecan-dlnk, Dato-Dxd), a Trop-2-directed antibody and topoisomerase inhibitor conjugate co-developed by Japan-based Daiichi Sankyo (TYO: 4568) and UK major AstraZeneca (AZ, NASDAQ: AZN), last week received approval from the US FDA for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor…
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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…
