TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company

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TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company

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Press Release

25

Nov, 2021

Transcenta Announces First Patient Dosed in Phase Ib Clinical Trial of its Humanized Anti-VEGFR-2 Monoclonal Antibody MSB0254

SUZHOU, China, November 25, 2021, Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces the successful dosing of first patient in Phase Ib Clinical Trial of MSB0254, a humanized anti-VEGFR-2 monoclonal antibody. MSB0254 has previously completed a Phase Ia clinical trial and established a Recommended Phase II Dose (RP2D).

13

Oct, 2021

Transcenta Announces CDE Acceptance of IND Application of its PD-L1/TGF-β Bi-functional Antibody TST005

SUZHOU, China, October 13, 2021, Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted IND application of its PD-L1/TGF-β bi-functional antibody TST005. Transcenta has received IND clearance for TST005 from US FDA on April 17, 2021 and the first US patient has been dosed in the global Phase I clinical trial on July 15, 2021.

27

Sep, 2021

Transcenta Received IND Clearance from NMPA of its Anti-sclerostin Monoclonal Antibody TST002

SUZHOU, China, September 27, 2021, Transcenta Holding Limited ("Transcenta"), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that it received IND clearance on Sept. 22 from NMPA for initiating Phase I clinical trial of TST002, a humanized sclerostin monoclonal antibody for postmenopausal osteoporosis.

18

Aug, 2021

Transcenta Held Investigator Meeting and Initiated Phase IIa Clinical Trial of Claudin18.2 Monoclonal Antibody TST001 with First Patient Dosed Successfully

SUZHOU, China, August 18, 2021, Transcenta announced that it held an investigator meeting successfully for TST001 Phase I clinical trial study on August 14. Professors Lin Shen and Jifang Gong from Beijing Cancer Hospital, Professor Weijian Guo from Fudan University Shanghai Cancer Center and other investigators from more than 40 hospitals nationwide attended the meeting and participated in the project discussion. Dr. Xueming Qian, CEO of Transcenta, Dr. Michael Shi, EVP, Head of Global R&D and CMO of Transcenta, and members of TST001-1002 project team attended the meeting.

28

Jul, 2021

Transcenta Announces Orphan Drug Designation Granted to TST001 for Treatment of Gastric and Gastroesophageal Junction

SUZHOU, China, July 28, 2021, Transcenta Holding Limited ("Transcenta"), a clinical stage global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to TST001, its anti-Claudin18.2 monoclonal antibody currently in Phase I clinical trial, for the treatment of patients with gastric cancer or gastroesophageal junction (GC/GEJ). According to preclinical and clinical data, TST001 displayed potent anti-tumor activities in tumor model of gastric cancer or patient of gastric cancer expressing Claudin18.2.

15

Jul, 2021

Transcenta Announces First Patient Dosed in Global Phase I Clinical Trial of PD-L1/TGF-β Bi-functional Antibody TST005

SUZHOU, China, July 15, 2021, Transcenta Holding Limited ("Transcenta"), a clinical stage global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, announces that the first US patient has been dosed in the global Phase I clinical trial of PD-L1/TGF-β bi-functional antibody TST005.

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