First Subject Dosed in the U.S. Phase I Trial for ASC43F Only Half a Month after IND Approval by the U.S. FDA
SHANGHAI, Nov. 18, 2021 /PRNewswire/ -- Gannex Pharma Co., Ltd., a wholly owned company of Ascletis Pharma Inc. (HKEX: 1672), today announces dosing of the first subject in the U.S. Phase I trial for ASC43F, a first-in-class, fixed-dose combination (FDC) oral tablet with dual targets of thyroid h...
Clinical Studies of PD-L1 Antibody ASC22 for HBV Functional Cure Selected for Inclusion in the "Best of The Liver Meeting's Summary" by AASLD Review Committee
-- Inclusion in the "Best of The Liver Meeting's Summary" is a singular honor and indicates the high level with which the AASLD review committee regards Ascletis' research in CHB -- In patients with the baseline HBsAg level ≤ 500 IU/mL, the Phase IIb study demonstrated sustained HBsAg loss in 19...
Gannex Announces China NMPA Approved Phase II and III Protocols of ASC42, an FXR Agonist, for Treatment of Primary Biliary Cholangitis
SHANGHAI, Nov. 15, 2021 /PRNewswire/ -- Gannex Pharma Co., Ltd., a wholly owned company of Ascletis Pharma Inc. (HKEX:1672) announces today that the protocols of Phase II and III clinical trials of ASC42 to treat patients with primary biliary cholangitis (PBC) has been approved by China National ...
Ascletis Announces Approval of Phase II Clinical Trial of ASC22 (Envafolimab) by China NMPA for Immune Restoration/Functional Cure of HIV-1 Infected Patients
HANGZHOU, China and SHAOXING, China, Nov. 10, 2021 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672) today announces the approval of the Phase II clinical trial of ASC22 (Envafolimab) by China National Medical Products Administration (NMPA) for the proposed new indication of immune restoration/fu...
Sustained Hepatitis B Surface Antigen Loss in Chronic Hepatitis B Patients with Subcutaneous PD-L1 Antibody ASC22 Treatment: Interim Results of Phase IIb Study
HANGZHOU, China and SHAOXING, China, Nov. 9, 2021 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672) announces today that the interim results of 44 chronic hepatitis B (CHB) patients from a Phase IIb trial of ASC22 (Envafolimab), a subcutaneously administered PD-L1 antibody (ClinicalTrials.gov Ide...
Ascletis and Suzhou Alphamab Expand their Partnership into Worldwide License Agreement for ASC22 (Envafolimab) to Treat Hepatitis B and Other Viral Diseases
HANGZHOU, China and SHAOXING, China and SUZHOU, China, Nov. 8, 2021 /PRNewswire/ -- Ascletis Pharma Inc. (1672.HK) and Suzhou Alphamab Co., Ltd. (Suzhou Alphamab) jointly announce today that Ascletis' subsidiary and Suzhou Alphamab have entered into an exclusive and worldwide license agreement ou...
Gannex Announces U.S. IND Approval of ASC43F, a First-in-Class Dual-Target Fixed-Dose Combination for NASH
SHANGHAI, Nov. 1, 2021 /PRNewswire/ -- Gannex Pharma Co., Ltd., a wholly owned company of Ascletis Pharma Inc. (HKEX: 1672), today announces the Investigational New Drug (IND) application approval by U.S. Food and Drug Administration (FDA) and initiation of global development of ASC43F, a first-...
Gannex Announces Clinical and Preclinical Data of Four NASH Programs to be Presented in Oral or Poster Presentation at The Liver Meeting® 2021 by American Association for the Study of Liver Diseases
SHANGHAI, Oct. 13, 2021 /PRNewswire/ -- Gannex Pharma Co., Ltd., a wholly owned company of Ascletis Pharma Inc. (HKEX:1672), announces today that the latest clinical and preclinical data of four NASH programs (ASC40/TVB-2640 co-authored with Sagimet Biosciences Inc., ASC41, ASC42 and ASC43F) will...
Ascletis Announces Results of the Phase IIa trial of ASC22 (Envafolimab) in Patients with Chronic Hepatitis B to be Presented in Oral Parallel Session at The Liver Meeting(R) 2021 by American Association for the Study of Liver Diseases
HANGZHOU and SHAOXING, China, Oct. 12, 2021 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672) announces today that the results of Phase IIa trial of subcutaneously administered PD-L1 antibody ASC22 (Envafolimab) in patients with chronic hepatitis B (CHB) will be presented in oral parallel session...
Gannex Announces Positive Topline Results from the U.S. Phase I Trial of Drug-Drug Interactions in Healthy Subjects and Pharmacokinetics in Patients with NAFLD for Its THRβ Agonist ASC41
SHANGHAI, Sept. 8, 2021 /PRNewswire/ -- Gannex, a wholly owned company of Ascletis Pharma Inc. (HKEX: 1672), today announces positive topline results from the U.S. Phase I trial of drug-drug interactions in healthy subjects and pharmacokinetics (PK) in patients with non-alcoholic fatty liver dise...
Gannex Announces Clinical Trial Application of ASC42, an FXR Agonist, for Treatment of Primary Biliary Cholangitis Accepted by China NMPA
SHANGHAI, Sept. 6, 2021 /PRNewswire/ -- Gannex Pharma Co., Ltd., a wholly owned company of Ascletis Pharma Inc. (HKEX:1672) announces today that the clinical trial application of ASC42 to treat patients with primary biliary cholangitis (PBC) has been accepted for review by China National Medical ...
Ascletis Announces Completion of the Bridging Study and Initiation of Phase II Trial of FXR Agonist ASC42 in China for Chronic Hepatitis B Indication
HANGZHOU and SHAOXING, China, Aug. 25, 2021 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672) announces today the completion of the bridging study and initiation of Phase II trial of farnesoid X receptor (FXR) agonist ASC42 inChina for chronic hepatitis B (CHB) indication. ASC42 is an in-house de...
Ascletis' Partner Sagimet Dosed First Patient in FASCINATE-2 Phase IIb Trial in NASH Patients with Moderate to Advanced Fibrosis
HANGZHOU and SHAOXING, China, Aug. 16, 2021 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX:1672) today announces that its partner Sagimet Biosciences dosed the first patient in its FASCINATE-2 Phase IIb clinical trial for non-alcoholic steatohepatitis (NASH). FASCINATE-2 is a randomized, double-blin...
China NMPA Approves Phase II Clinical Trial of ASC40 for the Treatment of Patients with Acne
HANGZHOU and SHAOXING, China, Aug. 9, 2021 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX code: 1672) today announces that China National Medical Products Administration (NMPA) has approved the Phase II clinical trial application of ASC40 for the treatment of patients with moderate to severe acne. T...
Ascletis Announces Completion of 149 Patient Enrollment and Positive Interim Results of Phase IIb Chronic Hepatitis B Study in China for its Subcutaneously Administered PD-L1 Antibody ASC22 (Envafolimab)
* HBsAg reduction was observed in the 1 mg/kg ASC22 once every two weeks plus nucleos(t)ide analogs group with greater HBsAg reduction observed in patients with HBsAg ≤ 500 IU/mL at baseline while no HBsAg reduction was observed for the placebo plus nucleos(t)ide analogs group * Receptor oc...
China NMPA Approves Phase III Clinical Trial of ASC40 Combined with Bevacizumab for Treatment of Patients with Recurrent Glioblastoma
HANGZHOU, China and SHAOXING, China, July 22, 2021 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX code: 1672) today announces that China National Medical Products Administration (NMPA) has approved the Phase III clinical trial application of ASC40 combined with Bevacizumab for treatment of patients w...
Ascletis Announces Dosing of the First Cohort of Healthy Subjects in the FXR Agonist ASC42 Bridging Study for Chronic Hepatitis B Indication in China
--This bridging study to select doses for the Phase II trial in China in patients with chronic hepatitis B (CHB) --ASC42 clinical trials are being conducted in the U.S. and China for non-alcoholic steatohepatitis (NASH) and CHB. HANGZHOU and SHAOXING, China, July 13, 2021 /PRNewswire/ -- A...
Gannex Announces Positive Topline Results of the U.S. Phase I Trial of NASH Drug ASC42, an FXR Agonist
SHANGHAI, June 16, 2021 /PRNewswire/ -- Gannex, a wholly owned company of Ascletis Pharma Inc. (HKEX: 1672), fully dedicated to the R&D and commercialization of new drugs in the field of non-alcoholic steatohepatitis (NASH), today announces positive topline results of safety and pharmacodynamic ...
Ascletis Received China IND Approval of Its FXR Agonist ASC42 for Chronic Hepatitis B Indication
HANGZHOU, China and SHAOXING, China, June 7, 2021 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672) today announces that China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for its drug candidate ASC42 to conduct clinical trials for ch...
Gannex Received China IND Approval of Its FXR Agonist ASC42 for NASH Indication
SHANGHAI, May 27, 2021 /PRNewswire/ -- Gannex, a wholly owned company of Ascletis Pharma Inc. (HKEX: 1672), fully dedicated to the R&D and commercialization of new drugs in the field of non-alcoholic steatohepatitis (NASH), today announces that China National Medical Products Administration (NMP...
