Ascletis Announces U.S. IND Approval of ASC22 (Envafolimab), a Subcutaneously Administered PD-L1 Antibody for Functional Cure of Chronic Hepatitis B
-- Estimated 1.59 million chronic hepatitis B (CHB) patients in the U.S. -- Interim results of the Phase IIb trial conducted on CHB patients in China showed that in patients with the baseline hepatitis B surface antigen (HBsAg) level ≤ 500 IU/mL, approximately 19% (3/16) of patients in the treatm...
Ascletis Announces First Patient Dosed in the Phase II Clinical Trial of FASN Inhibitor ASC40 for Treatment of Moderate to Severe Acne
HANGZHOU and SHAOXING, China, Jan. 13, 2022 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672) today announces the dosing of the first patient in the Phase II clinical trial of ASC40 for moderate to severe acne. ASC40 is an oral, selective inhibitor of fatty acid synthase (FASN), a key enzyme whic...
Ascletis Announces First Patient Dosed in the Phase II Clinical Trial of ASC42, An In-House Developed, Best-in-Class FXR Agonist for Chronic Hepatitis B Indication
HANGZHOU, China and SHAOXING, China, Jan. 11, 2022 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672) today announces the dosing of the first patient in the Phase II clinical trial of ASC42 for chronic hepatitis B (CHB) indication. The Phase II clinical trial (ClinicalTrials.gov Identifier: NCT051...
Ascletis Announces U.S. IND Filing for In-House Developed Oral PD-L1 Small Molecule Inhibitor ASC61 for Treatment of Advanced Solid Tumors
HANGZHOU, China and SHAOXING, China, Jan. 10, 2022 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672) announces today the filing of the U.S. Investigational New Drug (IND) application for in-house developed oral PD-L1 small molecule inhibitor, ASC61, for the treatment of advanced solid tumors. AS...
Gannex Announces Completion of the U.S. Phase I Trial of ASC43F, an In-House Developed First-in-Class Dual Targeting Fixed-dose Combination Tablet for NASH
* ASC43F was safe and well tolerated in healthy subjects with no clinically significant study drug related adverse events * Pharmacokinetic parameters of ASC41 and ASC42 from ASC43F are similar to those of ASC41 and ASC42 monotherapy * Phase I trial completed two months after the U.S. IND ap...
Ascletis Expands Ritonavir Oral Tablet Production and Announces Oral Direct-Acting Antiviral Pipeline Against SARS-CoV-2 Virus
- Ritonavir oral tablet annual production capacity has been expanded to 100 million tablets and can be further rapidly expanded based on market demand - ASC10 is an oral direct-acting antiviral drug candidate targeting RNA dependent RNA polymerase (RdRp) to treat SARS-CoV-2 infection - ASC11 is ...
Ascletis Announces Inclusion in New Catalogue of China National Reimbursement Drug List (NRDL) of ASCLEVIR®/ GANOVO® Regimen, an All-oral Direct Anti-HCV Therapy
HANGZHOU, China and SHAOXING, China, Dec. 3, 2021 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672) today announces that its all-oral direct anti-hepatitis C virus (HCV) ASCLEVIR® (Ravidasvir)/ GANOVO® (Danoprevir) regimen has been included in the Medicine Catalog for National Basic Medical Insu...
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...
