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Gan & Lee Pharmaceuticals Doses First Patient in GZR4 Phase III Study for Diabetes
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China-based Gan & Lee Pharmaceuticals (SHA: 603087) announced that the first patient has been dosed in a Phase III clinical study for GZR4, its Category 1 therapeutic biologic product. GZR4 is an investigational ultra-long-acting insulin designed for once-per-week subcutaneous injection to treat diabetes. Drug ProfileGZR4 aims to provide a convenient…
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Stedical Scientific Raises RMB100M in Series B Financing for Global Expansion
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Stedical Scientific, a Hangzhou-based tissue engineering and regenerative medicine company, has raised over RMB100 million (USD13.7 million) in a Series B financing round co-led by Lapam Capital and Shanghai Healthcare Capital. The funds will support the commercial expansion of its core products, particularly in the US and China, as well…
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Zelgen Biopharmaceuticals’ ZG005 Bispecific Antibody Receives NMPA Approval for Biliary Tract Cancer Trials
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China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its pipeline candidate ZG005. The Category 1 biologic product will be tested in combination with a platinum-containing chemotherapy regimen for advanced biliary tract cancer. Drug ProfileZG005…
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Bristol-Myers Squibb Releases Five-Year Data on Sotyktu’s Long-Term Efficacy and Safety
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In a recent announcement, US pharmaceutical giant Bristol-Myers Squibb (BMS, NYSE: BMY) unveiled the latest five-year results from its POETYK PSO long-term extension study. The study evaluates the sustained efficacy and safety of Sotyktu (deucravacitinib), a groundbreaking treatment for adults with moderate-to-severe plaque psoriasis. Sotyktu, recognized as the world’s first…
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Wanbangde New Building Materials’ Mecobalamin Earns FDA Orphan Drug Designation for ALS
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China’s Wanbangde New Building Materials Co., Ltd (SHE: 002082) announced that its mecobalamin product has received an orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of amyotrophic lateral sclerosis (ALS). The designation highlights the drug’s potential to address unmet medical needs in ALS,…
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Biokin Pharmaceutical Registers Phase III Study for BL-B01D1 in EGFR Mutant NSCLC
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has registered a Phase III study on chinadrugtrials.org.cn to evaluate the efficacy of BL-B01D1 combined with osimertinib versus osimertinib alone as a first-line therapy for EGFR mutant locally advanced or metastatic non-small cell lung cancer (NSCLC). The study, led by Professor Zhou Caicun…
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AccurEdit’s ART002 Becomes First In Vivo Gene Editing Product to Reduce LDL-C in Humans
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Suzhou-based gene editing specialist AccurEdit Therapeutics announced that its in vivo gene editing product, ART002, has achieved drug saturation and safely reduced low-density lipoprotein cholesterol (LDL-C) with a single dose in a multi-center, open, single-arm, exploratory investigator-initiated trial (ITT) for heterozygous familial hypercholesterolemia. This marks the first time an in…
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Beihai Biotech Licenses Beizary to Zydus Lifesciences for US Market
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China-based Zhuhai Beihai Biotech Co., Ltd announced a licensing agreement with Zydus Lifesciences, granting the India-headquartered firm exclusive commercialization rights to Beizary, a modified version of docetaxel, in the United States. Deal TermsUnder the agreement, Beihai will handle manufacturing and supply of Beizary. The company will receive an upfront payment…
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Huadong Medicine’s HDM1005 Shows Positive Results in Phase Ia/Ib Study
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced positive results from the Phase Ia/Ib study of HDM1005, a long-acting agonist targeting the GLP-1 and GIP receptors, in China. Study Details Safety ResultsThe most common adverse reactions were decreased appetite and gastrointestinal issues (nausea, vomiting, bloating), which were mild to moderate…
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PolyMed Biopharma Licenses HPB-143 to Photys Therapeutics for Global Development
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PolyMed Biopharma, a Hangzhou-based developer of Proteolysis Targeting Chimera (PROTAC) drugs, has entered into a licensing agreement with U.S.-based Photys Therapeutics, Inc. for its HPB-143, a targeted protein degrader (TPD) targeting IRAK4. Under the agreement, Photys will obtain exclusive global development, manufacturing, and commercialization rights to the drug, excluding Greater…
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Samsung Bioepis’ Ospomyv and Xbryk Gain FDA Approval for RANKL Inhibitor Biosimilars
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South Korea-based Samsung Bioepis Co., Ltd. announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its Ospomyv (denosumab-dssb; SB16; 60 mg pre-filled syringe) and Xbryk (denosumab-dssb; SB16; 120 mg vial), biosimilars of US major Amgen’s RANKL inhibitors Prolia and Xgeva, respectively. Additionally, the…
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Kexing Biopharm’s GB05 Receives FDA Approval for Pediatric RSV Infections
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China-based Kexing Biopharm Co., Ltd. (SHA: 688136) announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its human interferon α1b inhalation solution, GB05. The drug is designed to treat pediatric lower respiratory tract infections caused by respiratory syncytial virus (RSV), such as…
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Sanofi’s Merilog Biosimilar Wins FDA Approval for Diabetes Treatment
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The U.S. Food and Drug Administration (FDA) has approved Sanofi-Aventis’ (EPA: SAN) Merilog, a biosimilar of Novo Nordisk’s (NYSE: NVO) NovoLog. Merilog, a rapid-acting insulin, is indicated for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. The approval includes both a 3 milliliter (mL) single-patient-use…
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![Yantai Dongcheng’s Lannacheng Bio Secures RMB150m to Advance [18F] Spiritide Study](https://flcube.com/wp-content/uploads/2025/02/1709-png.avif)
Yantai Dongcheng’s Lannacheng Bio Secures RMB150m to Advance [18F] Spiritide Study
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675)’s controlling subsidiary, Yantai Lannacheng Biotechnology Co., Ltd., has secured RMB150 million (USD20.7 million) in funding from three new investors: Wenzhou Ruili Medical New Consumer Industry Investment Partnership, Shanghai Linjue Enterprise Management, and Shanghai Hanchengming Enterprise Management, as well as its parent company…
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GSK’s Penmenvy Meningococcal Vaccine Approved by FDA for Ages 10-25
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UK-based multinational GSK plc (LON: GSK) announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its Penmenvy (meningococcal groups A, B, C, W, and Y vaccine) for use in individuals aged 10 through 25 years. The vaccine targets the five major serogroups of…
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3SBio and Sichuan Biokin Partner to Advance Solid Tumor Treatment in China
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China-based 3SBio Inc. (HKG: 1530) has announced a strategic partnership with fellow domestic firm Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506). The collaboration aims to advance the exploration of combining 3SBio’s 707 and Sichuan Biokin’s BL-B01D1 for the treatment of solid tumors in mainland China. Drug Profiles Collaboration DetailsThe partnership…
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LINDIS Biotech’s Korjuny Approved by European Commission for Malignant Ascites
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Germany-based LINDIS Biotech GmbH announced that it has received market approval from the European Commission (EC) for its Korjuny (catumaxomab), making the trifunctional anti-CD3 x anti-EpCAM antibody (trAb) the only approved therapy for patients with malignant ascites (MA) across Europe. Drug BackgroundCatumaxomab was originally discovered by German firm Trion Pharma…
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IASO Bio’s Fucaso NDA Accepted by Hong Kong DOH for Relapsed/Refractory Multiple Myeloma
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China-based IASO Bio announced that a New Drug Application (NDA) for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy Fucaso (equecabtagene autoleucel) has been accepted for review by the Hong Kong Department of Health (DOH). The application is for the treatment of relapsed/refractory multiple myeloma (R/R MM) in patients…
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Innovent Biologics’ IBI363 Receives FDA Fast-Track Designation for sqNSCLC
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China-based Innovent Biologics, Inc. (HKG: 1801) announced that it has received another fast-track designation from the US Food and Drug Administration (FDA) for its IBI363. The PD-1/IL-2α bispecific antibody fusion protein, previously granted fast-track status for melanoma, has now been awarded the designation for the treatment of unresectable, locally advanced,…
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Tianyi Medical Acquires Bellco’s CRRT Filter Business for EUR11.99m
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Tianyi Medical (SHE: 301097), a Ningbo-based developer of Class III medical consumables, has announced plans to acquire the CRRT-filter business assets of Italy-based Bellco S.R.L., a leader in blood purification treatments, for EUR11.99 million (USD12.59 million). Acquisition DetailsThe acquisition is set to position Tianyi Medical as the third company globally…
