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Bayer Files for Finerenone Approval in US and China for Heart Failure-Fineline Info & Tech
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Bayer AG (ETR: BAYN) has announced market filings with the US Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for its drug finerenone. The German pharmaceutical giant is seeking approvals in both countries for the mineralocorticoid receptor (MR) antagonist…
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Changchun High & New Technology Industries Receives FDA Approval for GenSci098 Clinical Trial in Thyroid Eye Disease
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Changchun High & New Technology Industries (Group) Inc., a Chinese corporation listed on the Shenzhen Stock Exchange (SHE: 000661), has received tacit approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its Category 1 biologic product, GenSci098. This humanized anti-TSHR antagonistic monoclonal antibody (mAb)…
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AccurEdit Therapeutics Receives CDE Approval for Gene Editing Drug ART001 Targeting Amyloidosis
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AccurEdit Therapeutics (Suzhou) Co., Ltd, a leading specialist in gene editing therapies based in China, has received approval from the Center for Drug Evaluation (CDE) for its investigational drug ART001. This drug is designed to target transthyroxine protein amyloidosis, a severe genetic disorder. ART001 marks a significant advancement in China’s…
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3SBio Secures Exclusive Licensing Agreement for Seven Drug Candidates from Subsidiary
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, a subsidiary of 3SBio Inc. (HKG: 1530), has disclosed plans to enter into an exclusive licensing agreement with its parent company. Under this agreement, Guojian will grant 3SBio the Greater China rights to seven pipeline candidates, including 706, 709, HBT-2002, QY-F10, QY-F11, QY-F07, and…
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AccurEdit Therapeutics Publishes Positive Data for Gene-Edited Drug ART001 in Amyloidosis Treatment
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AccurEdit Therapeutics (Suzhou) Co., Ltd., a leading gene editing therapy specialist based in China, has published the efficacy and safety data for its drug candidate ART001, which is being investigated as a treatment for transthyroxine protein amyloidosis. ART001, the first non-viral vector in vivo gene-edited drug in China to enter…
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IASO Biotherapeutics Gains FDA Nod for Fucaso CAR-T Study in Myasthenia Gravis
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China-based IASO Biotherapeutics has received approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical study for Fucaso (equecabtagene autoleucel), a BCMA-directed CAR-T cell therapy targeting refractory systemic myasthenia gravis (MG). Earlier this year, IASO began a clinical trial for Fucaso in China for the same indication.…
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AstraZeneca’s Enhertu Receives Priority Review for Expanded HER2-positive Solid Tumor Indication
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UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced that an indication extension filing for Enhertu (trastuzumab deruxtecan), submitted in partnership with Japan’s Daiichi Sankyo (TYO: 4568) to the US Food and Drug Administration (FDA), has been granted priority review. The treatment is now under consideration for unresectable or metastatic…
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TG ImmunoPharma’s Bispecific Antibody TGI-6 Approved for Phase I Clinical Study by NMPA
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China-based TG ImmunoPharma Co., Ltd has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its bispecific antibody (BsAb) TGI-6 in China. This approval marks a significant milestone in the development of innovative cancer treatments within the country.…
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Cascade Pharmaceuticals Secures RMB140 Million in Financing to Advance FXR Agonist Clinical Trials
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Shanghai-based sino-foreign joint venture, Cascade Pharmaceuticals, Inc., has reportedly raised RMB140 million in a recent financing round. The investors included a prestigious group of Puhua Capital, CAS Investment, HD Capital, Lapam Capital, and New Act Investment. The funds raised will be directed towards intensifying Phase II clinical studies for their…
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Beyond Therapeutics Secures Tens of Millions in Pre-Series A Financing for Ophthalmology and Oncology Pipeline
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Beyond Therapeutics Co., Ltd., a biotechnology company based in Suzhou with a focus on ophthalmology and oncology, has reportedly raised tens of millions of renminbi in a Pre-Series A financing round. The round was led by Ming Bioventures, with contributions from Highpower Industrial and 3D BioOptima. The funds will be…
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Jiangsu Kanion Pharmaceutical Gets FDA Approval for KYS202002A Clinical Study in Multiple Myeloma
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China-based Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced receiving the green light from the US Food and Drug Administration (FDA) to conduct a clinical study for its pipeline candidate KYS202002A, focusing on recurrent/refractory multiple myeloma (R/R MM). This follows the molecule’s approval for clinical trials in China in…
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uBriGene Partners with Everlife Biomed to Advance iPSC Therapy Preparation
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China-based uBriGene, a leading cell and gene therapy contract development and manufacturing organization (CDMO), has announced a strategic partnership with Everlife Biomed (Beijing) Co., Ltd., a biopharmaceutical company specializing in human immune privilege cell technology. The collaboration will focus on the development of induced pluripotent stem cells (iPSC) therapy preparations,…
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TYK Medicines Partners with WuXi STA for Comprehensive CMC Services
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Shanghai-based TYK Medicines has announced a partnership with WuXi STA, a subsidiary of WuXi AppTec (SHA: 603259), to enhance their collaboration in the field of Chemistry, Manufacturing, and Controls Development (CMC) services. According to the agreement, WuXi STA will serve as a strategic partner to TYK Medicines, offering one-stop services…
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TYK Medicines Receives CDE Approval for CDK7 Inhibitor TY-2699a Clinical Study
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Shanghai-based TYK Medicines has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a clinical study for its small molecule drug candidate, TY-2699a. This oral, selective CDK7 inhibitor is under development for the treatment of various cancers, including breast, ovarian, prostate, pancreatic, and small…
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Coherent Biopharma Secures $100 Million in Series B and B+ Financings for Clinical Pipeline
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Coherent Biopharma Ltd, a specialist in bispecific-ligand drug conjugates (Bi-XDC) headquartered in Suzhou, has declared the successful completion of Series B and Series B+ financing rounds, totaling $100 million. The initial Series B round was led by HM with support from Yuanfeng Capital, V Capital, 6 Dimensions Capital, Agricultural Bank…
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Sunshine Guojian Pharmaceutical and Shenyang 3SBio Secure Exclusive Licensing Agreement for Antitumor Programs
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, a subsidiary of 3SBio Inc. (HKG: 1530), has announced plans to enter into an exclusive licensing agreement with Shenyang 3SBio Co., Ltd. The deal grants 3SBio extensive rights, including development, regulatory, manufacturing, use, sales, export, and import, for its antitumor programs 602, 609, 705,…
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Ubrigene Secures RMB 150 Million in Series C+ Financing to Expand Global CGT CDMO Platform
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Yiming Cell Biotechnology Co., Ltd, known as Ubrigene Biosciences Inc., a leading gene and cell therapy contract development and manufacturing organization (CDMO) based in Beijing, has reportedly raised RMB 150 million (USD 21.8 million) in a Series C+ financing round. The funding was led by Guotai Junan Innovation Investment and…
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Huadong Medicine Reports 9.12% YOY Revenue Growth and 13.24% Increase in Net Profits for 2022
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Huadong Medicine Co., Ltd (SHE: 000963), a leading China-based pharmaceutical company, has released its 2022 financial report, demonstrating robust growth with revenues of RMB 37.715 billion (USD 5.5 billion), an increase of 9.12% year-on-year (YOY), and net profits of RMB 2.598 billion (USD 379.3 million), marking a 13.24% YOY increase.…
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Allorion Therapeutics Raises USD 50 Million in Series B Financing to Advance Drug Development
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Allorion Therapeutics, a next-generation precision medicine small molecule drug developer based in Guangzhou, reportedly raised USD 50 million in a Series B financing round. The round was led by INCE Capital and Qiming Venture Partners, with contributions from TF Capital, LongRiver Investments, 3SBio, Octagon Capital, and Lichen Private Equity Fund.…
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Jing Medicine’s HJM-353 Gains Clinical Trial Approvals in US and China
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China-based Jing Medicine Technology (Shanghai) Co., Ltd’s HJM-353 has obtained clinical trial approvals in the US and China. The investigational embryonic ectoderm development (EED) inhibitor is expected to enter a Phase I clinical study for advanced blood cancer and solid tumors. Mechanism of Action and DevelopmentPolycomb repressive complex 2 (PRC2)…
