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Lepu Biotechnology’s MRG003 Receives Orphan Drug Designation from FDA
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China-based Lepu Biotechnology Co., Ltd (HKG: 2157) has announced that it has received orphan drug designation (ODD) status from the US FDA for its core product MRG003, an epidermal growth factor receptor targeted antibody drug conjugate (ADC) for the treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). Drug Mechanism and DevelopmentMRG003…
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CARsgen Therapeutics Presents Positive Phase Ib/II Data for CT053 at CAR-TCR Summit
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China-based CARsgen Therapeutics Holdings Ltd presented the results of a multi-center, open-label Phase Ib/II study assessing the safety and efficacy of its B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor (CAR) T cell therapy CT053 (zevor-cel) at the 7th CAR-TCR Annual Summit. The study is being conducted across North America, focusing…
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BeiGene’s Brukinsa Receives New EU and UK Indications for BTK Inhibitor
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China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has received two new indication recommendations in the EU and the United Kingdom for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib). The approvals expand the therapeutic applications of this innovative treatment, further solidifying its position in the global oncology…
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Alphamab Oncology Doses First Patient in Phase I Study for JSKN003 in Australia
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Alphamab Oncology (HKG: 9966) has announced that the first patient has been dosed in a Phase I clinical study for its JSKN003-KN026 antibody drug conjugate (ADC) in Australia. The open, multi-center, dosage escalation Phase I study is designed to assess the safety, tolerability, and preliminary efficacy of JSKN003 in advanced…
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Daehwa Pharmaceutical Files NDA for Liporaxel in China for Gastric Cancer Treatment
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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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Antengene’s ATG-101 Receives Orphan Drug Designation for Pancreatic Cancer
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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’s Lecheng Zone Updates Special Drug Insurance List with Expanded Coverage
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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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Antengene Expands to Australia with New Melbourne Office
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China-based biotech firm Antengene (HKG: 6996) announced the opening of its new office in Melbourne, Australia. This strategic move is aimed at supporting the company’s expansion in the Asia Pacific region, with the office covering functions including commercial operations, finance, medical affairs, and clinical and business development. Clinical Trials and…
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Transcenta’s First-in-Class Gremlin1 Antibody TST003 Receives FDA IND Clearance
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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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Alphamab/3DMed’s Envafolimab Gains FDA Fast-Track Status for Sarcoma Treatment
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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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Buchang Pharmaceuticals Gains NMPA Approval for BC008-1A Clinical Study
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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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CDE Prioritizes Review of Pearl Bio’s Breatinib for NSCLC Treatment
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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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Jiangsu Hengrui Medicine Gains NMPA Approval for HRS-6209 Clinical Study
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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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Takeda’s Modakafusp Alfa and TAK-981 Gain NMPA Clinical Trial Approvals
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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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InnoCare Pharma’s BCL2 Inhibitor ICP-248 Gains NMPA Approval for Clinical Study
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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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Transcenta’s TST001 Shows Promise in Gastric Cancer Trial with 73.3% Response Rate
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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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Dizal Pharma’s Sunvozertinib Gains NMPA Approval for EGFR Mutation NSCLC Trial
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its next-generation epidermal growth factor receptor (EGFR) inhibitor sunvozertinib (DZD9008) combined with bevacizumab in locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutation. Ongoing…
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Keymed and Lepu’s CMG901 Receives Breakthrough Therapy Designation for Gastric Cancer
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The Center for Drug Evaluation (CDE) website indicates that CMG901, a Claudin 18.2 (CLDN18.2)-targeted antibody drug conjugate (ADC) co-developed by Keymed Biosciences Inc. and Lepu Biopharma Co., Ltd, has obtained breakthrough therapy designation (BTD) status. The designation is specifically for the drug’s potential use in CLDN18.2-positive advanced gastric cancer in…
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Laekna Therapeutics Doses First Patient in LAE001/LAE002 Study for Prostate Cancer
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China-based Laekna Therapeutics Shanghai Co., Ltd announced that the first patient has been dosed in the Phase I/II LAE201INT2101 study evaluating the combination of LAE001 and LAE002 (afuresertib) in South Korea. The multi-regional clinical trial (MRCT) now spans China, the United States, and South Korea. Study DetailsLAE201INT2101 is a multi-center,…
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Innovent’s Tyvyt Combo Shows PFS Benefit in EGFR-Mutant NSCLC
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China-based Innovent Biologics Inc. (HKG: 1801) announced positive results from the Phase III ORIENT-31 study evaluating the combination of its PD-1 inhibitor Tyvyt (sintilimab) and Byvasda (bevacizumab biosimilar) in patients with EGFR-mutated non-squamous non-small cell lung cancer (nsqNSCLC) who have progressed after EGFR tyrosine kinase inhibitor (TKI) treatment. The study…
