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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.…
