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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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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 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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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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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…
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The National Medical Products Administration (NMPA) has released the 58th batch of reference drugs for generic quality consistency evaluation (GQCE) work. This batch includes a total of 41 new specifications, among which 13 are injectables. The release aims to further standardize the quality of generic drugs in the Chinese market,…
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Alphamab Oncology (HKG: 9966) and 3D Medicines’ envafolimab (KN035) has obtained fast-track status from the US Food and Drug Administration (FDA) for the treatment of locally advanced, unresectable, or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) that have progressed after chemotherapy. This designation is expected to accelerate the development…
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced the successful completion of a multi-center, randomized double-blinded, placebo parallel controlled Phase II clinical study for its jakinib, a Janus kinase (JAK) inhibitor, in patients with active ankylosing spondylitis (AS). The study demonstrated robust results, meeting the pre-set statistical standards and showing…
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China-based Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 biologic product BC008-1A in advanced solid tumors. This marks a significant step forward in the development of BC008-1A as a…
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The Center for Drug Evaluation (CDE) website indicates that Beijing Pearl Biotechnology Co., Ltd’s APL-101/PLB1001 (breatinib), a small molecule kinase inhibitor targeting c-MET, is set for priority review for its use in treating locally advanced or metastatic non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition factor (MET) exon 14 skipping.…
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its investigational drug HRS-6209 in patients with advanced solid tumors. This marks a significant step forward in the development of HRS-6209 as a…
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China-based I-Mab (NASDAQ: IMAB) announced that it has successfully completed an End-of-Phase 2 (EoP2) meeting with the Center for Drug Evaluation (CDE) in China and obtained approval to initiate a Phase III registrational trial assessing lemzoparlimab, a novel CD47 antibody, in combination with azacitidine (AZA) as a first-line treatment for…
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The National Medical Products Administration (NMPA) website indicates that Japan-based Takeda Pharmaceutical Co., Ltd’s (TYO: 4502) modakafusp alfa and subasumstat (TAK-981) have obtained tacit clinical trial approvals. The targeted indications are multiple myeloma (MM) and CD20-positive relapsed/refractory non-Hodgkin’s lymphoma (NHL) combined with rituximab, respectively. TAK-573: A First-in-Class Drug for Relapsed/Refractory…
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) announced that it has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its generic version of Swiss giant Novartis’ Gilenya (fingolimod). The application was filed by Huahai’s US unit, Prinston Pharmaceutical Inc. Drug Background…
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China-based Luye Pharma Group (HKG: 2186) announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study of its LY03015. The study will assess the safety, tolerability, and pharmacokinetics of the next-generation vesicular monoamine transporter 2 (VMAT2) inhibitor. LY03015 is…
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China’s Beijing InnoCare Pharma (HKG: 9969) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its in-house developed BCL2 inhibitor, ICP-248. This Category 1 innovative drug becomes the company’s fifth drug to reach clinical trials in the blood cancer field…
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BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) presented the latest results of the global Phase III RATIONALE 301 study evaluating tislelizumab in first-line unresectable hepatocellular carcinoma (HCC) at the 2022 European Society for Medical Oncology (ESMO) meeting. The study, which enrolled 674 patients in the US, Europe, and Asia, met…
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China-based Luye Pharma Group (HKG: 2186) announced that its subsidiary Shandong BoAn Biotechnology Co., Ltd’s BA-CovMab, a broad-spectrum neutralizing antibody against COVID-19, has obtained clinical trial approval from the National Medical Products Administration (NMPA). Mechanism of ActionBA-CovMab is a recombinant fully human monoclonal neutralizing antibody obtained through sequential immunization and…
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China-based biotech Transcenta Holdings Ltd (HKG: 6628) announced interim safety and efficacy data from a Phase I/II study of TST001 (osemitamab), a humanized ADCC-enhanced anti-Claudin18.2 monoclonal antibody (mAb), in combination with capecitabine and oxaliplatin (CAPOX) as a first-line treatment for locally advanced or metastatic gastric or gastroesophageal junction (GC/GEJ) cancer.…
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China-based CSPC Pharmaceutical Group Co., Ltd (HKG: 1093) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct separate clinical trials for its Category 1 biologic product TG103 in non-alcoholic steatohepatitis (NASH) and Alzheimer’s disease (AD). This marks a significant step forward in the development…