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Henlius Biotech’s Serplulimab Accepted for EMA Review for ES-SCLC Treatment
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Shanghai Henlius Biotech (HKG: 2696) has announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for its programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab). The drug is filed for its first indication as a first-line treatment in combination with chemotherapy for extensive-stage small cell lung cancer…
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AstraZeneca’s Calquence Receives Conditional Approval in China for MCL
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AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received conditional market approval in China for its next-generation Bruton’s tyrosine kinase (BTK) inhibitor, Calquence (acalabrutinib). The drug is approved for the first indication in adults with mantle cell lymphoma (MCL) who have received at least one prior therapy. Clinical Trial…
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Hinova Pharmaceuticals’ HC-1119 NDA Accepted for Review by NMPA
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Chengdu-based biotech Hinova Pharmaceuticals Inc. (SHA: 688302) has announced that the New Drug Application (NDA) filing for its Category 1 drug HC-1119 has been accepted for review by the National Medical Products Administration (NMPA). The intended indication is for patients with metastatic castrate-resistant prostate cancer (mCRPC) who have failed to…
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Boehringer Ingelheim Initiates Phase III FIBRONEER Studies for PDE4B Inhibitor BI 1015550
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German pharmaceutical giant Boehringer Ingelheim (BI) has announced the first patient enrollments in the Phase III FIBRONEER studies for its phosphodiesterase 4b (PDE4B) inhibitor, BI 1015550. The studies are focused on idiopathic pulmonary fibrosis (IPF) and progressive fibrosis interstitial lung disease (PF-ILD), two conditions with limited treatment options. Global Study…
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Advenchen Lab’s AL8326 and Hengrui’s SHR-A1811 Receive Breakthrough Therapy Designations
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The Center for Drug Evaluation (CDE) website indicates that Advenchen Lab’s AL8326 and Hengrui Pharmaceuticals’ (SHA: 600276) SHR-A1811 have been awarded separate breakthrough therapy designations (BTDs). This recognition highlights the potential of both drugs to significantly improve the treatment of cancer patients. Advenchen’s AL8326: A Promising TKI InhibitorAdvenchen’s drug candidate…
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Biokin’s BL-B01D1 Receives NMPA Approval for Phase II Solid Tumor Study
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China-based Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study assessing the efficacy and safety of its drug candidate BL-B01D1 as a treatment for solid tumors. The study will evaluate the…
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Junshi Biosciences’ JS010 Receives NMPA Approval for Migraine Clinical Trials
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its JS010, an in-house developed CGRP-targeted monoclonal antibody (mAb) drug candidate for the treatment of migraines. CGRP and Its Role in MigrainesCGRP is a neuropeptide composed…
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Immunotech Biopharm’s CAR-T-19-D2 Receives NMPA Approval for DLBCL Clinical Trial
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China-based chimeric antigen receptor T-cell (CAR-T) specialist Immunotech Biopharm Ltd (HKG: 6978) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its CAR-T-19-D2 (CAR-T-19-DNR or RC19D2) in recurrent/refractory diffuse large B-cell lymphoma (DLBCL). Mechanism of Action and Clinical NeedCAR-T-19-D2 targets the CD19…
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Reistone Biopharma’s Ivarmacitinib Shows Positive Results in Phase III QUARTZ3 Study
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Reistone Biopharma Co., Ltd, incubated by Hengrui Pharmaceuticals (SHA: 600276) with USD 100 million in 2018, has released interim data from the 16-week mark in the Phase III QUARTZ3 study. The study is assessing the efficacy of the JAK1 inhibitor ivarmacitinib in patients with moderate to severe atopic dermatitis (AD).…
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Yifan Pharmaceutical’s F-652 Cleared for Phase II Trial in Alcoholic Hepatitis
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China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) has announced that its subsidiary Evive Biotech Ltd’s F-652 has been cleared to start a Phase II clinical trial for a new indication by China’s National Medical Products Administration (NMPA). The trial will assess F-652 as a treatment for alcoholic hepatitis (AH). Mechanism…
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Yiling Pharmaceutical’s BIO-008 Receives NMPA Approval for Clinical Trials
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China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its novel biologic product BIO-008. This marks a significant milestone in the development of the company’s innovative therapeutic biologic. Development and IndicationsBIO-008 is a monoclonal antibody…
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Hengrui Pharmaceuticals’ SHR8028 Receives NMPA Review for Dry Eye Treatment
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that a market approval filing for SHR8028, an anti-inflammatory and immunomodulatory agent under development to treat dry eye, has been accepted for review by the National Medical Products Administration (NMPA) in China. Clinical Study and ResultsThe filing is based on…
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Jiangsu Recbio’s ReCOV Vaccine Receives Emergency Use Authorization in Mongolia
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China-based vaccine maker Jiangsu Recbio Technology Co., Ltd (HKG: 2179) has announced that it has received Emergency Use Authorization (EUA) from Mongolia for its ReCOV, a recombinant COVID-19 vaccine co-developed by the Chinese Academy of Sciences. This authorization marks a significant milestone in the global distribution and accessibility of the…
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Luye Pharma’s BA1102 Biosimilar to Xgeva Accepted for CDE Review
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China-based Luye Pharma Group (HKG: 2186) has announced that a market approval filing for its subsidiary Shandong Boan Biotechnology Co., Ltd’s BA1102, a biosimilar version of Amgen’s (NASDAQ: AMGN) Xgeva (denosumab), has been accepted for review by the Center for Drug Evaluation (CDE). Indications and Market ContextDenosumab is a monoclonal…
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Bayer’s Nubeqa Receives Additional NMPA Approval for mHSPC Treatment-Fineline Info & Tech
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German pharmaceutical giant Bayer AG (ETR: BAYN) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its drug Nubeqa (darolutamide). The drug, which was previously approved for use in non-metastatic castration-resistant prostate cancer (nmCRPC) in February 2021, can now be used to…
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NMPA Denies Market Approval for Hengrui’s Plinabulin in Chemotherapy-Induced Neutropenia
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) announced in a stock exchange statement that the National Medical Products Administration (NMPA) has declined to issue a market approval for plinabulin, a potential first-in-class GEF-H1-targeted small-molecule drug in-licensed from US-based BeyondSpring Inc. (NASDAQ: BYSI). Hengrui was seeking approval for the drug’s use…
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SciClone Pharmaceuticals’ Vaborem Approved for Phase III Clinical Trial in China
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SciClone Pharmaceuticals Inc (HKG: 6600) has announced that a clinical trial filing for its Vaborem (meropenem vaborbactam), a new antibacterial drug, has been approved by the National Medical Products Administration (NMPA). This approval allows the drug to enter a Phase III clinical study in China. Study Objectives and DesignThe Phase…
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Janssen Withdraws Carvykti from UK Market Amid Manufacturing Concerns
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US-based Janssen Pharmaceutical reportedly decided to withdraw Carvykti (ciltacabtagene autoleucel; cilta-cel) from the UK market last week. The BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, which is under development globally by Janssen in partnership with China-based Legend Biotech (NASDAQ: LEGN), was being assessed by the UK’s National Institute of…
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Hainan Poly Pharm’s Generic Gadovist Receives FDA Approval for MRI Use
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced that it has received marketing approval from the US FDA for its generic version of German giant Bayer’s (ETR: BAYN) Gadovist (gadobutrol injection). The drug is approved for use in contrast-enhanced magnetic resonance imaging (CE-MRI) examination of lesions in various…
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Jacobio Pharma’s JAB-24114 Receives CDE Approval for Phase I/IIa Clinical Study
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China-based Jacobio Pharma (HKG: 1167) has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a Phase I/IIa clinical study for its in-house developed JAB-24114, a glutaminase enzyme (GUE) inhibitor. This marks a significant step forward in the development of innovative cancer therapies. Mechanism…
