Ascletis Announces Submission of Marketing Authorization Applications for Ritonavir in Eight Additional European Countries
-- Ritonavir marketing authorization applications have been submitted to Spain, Portugal, Italy, Belgium, Poland, Sweden, the Netherlands and Denmark HANGZHOU, China and SHAOXING, China, March 1, 2022 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672) today announces that it has submitted marketin...
Shanghai Public Health Clinical Center Initiated Functional Cure Study of Anti-PD-L1 Antibody ASC22 (Envafolimab) in Combination With Chidamide in HIV-Infected Patients
HANGZHOU, China and SHAOXING, China, Feb. 14, 2022 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672) today announces that Shanghai Public Health Clinical Center initiated functional cure study of anti-PD-L1 antibody ASC22 (Envafolimab) in combination with Chidamide in patients infected by human ...
Ascletis Announces Submission of Marketing Authorization Applications for Ritonavir in Multiple European Countries
HANGZHOU, China and SHAOXING, China, Feb. 13, 2022 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672) today announces that it has submitted marketing authorization applications for ritonavir (100 mg film-coated tablet) inGermany, France, Ireland and United Kingdom through its agent in Europe. It i...
Ascletis Announces Positive Data of Oral Double Prodrug ASC10 and Its Antiviral Nucleoside Analog ASC10-A Against Omicron Variant
* ASC10-A demonstrated strong in vitro antiviral activity against multiple SARS-CoV-2 virus variants including Omicron * By applying a double prodrug strategy, ASC10's permeability in Caco-2 cells and ASC10's oral bioavailability in monkeys were 3.2-fold and 2.3-fold of Molnupiravir, respecti...
Ascletis Announces U.S. IND Approval of Oral PD-L1 Small Molecule Inhibitor ASC61 for Treatment of Advanced Solid Tumors
* The objectives of the U.S. Phase I trial are to find a recommended Phase II dose and obtain preliminary efficacy in patients with advanced solid tumors * The first U.S. patient is expected to be dosed in the first half of 2022 * ASC61 shows significant antitumor efficacy as a single agent i...
Ascletis Announces IND Filing of Its Second FASN Inhibitor ASC60 for Advanced Solid Tumors Accepted by China NMPA
HANGZHOU, China and SHAOXING, China, Jan. 26, 2022 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX code: 1672) today announces that following the consultation with China National Medical Products Administration (NMPA), the Investigational New Drug (IND) application of its second fatty acid synthase (F...
Ascletis Announces First Patient Dosed in the Phase III Clinical Trial of FASN Inhibitor ASC40 Combined with Bevacizumab for Treatment of Recurrent Glioblastoma
HANGZHOU and SHAOXING, China, Jan. 23, 2022 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX code: 1672) today announces the dosing of the first patient in the Phase III registration clinical trial of ASC40 combined with bevacizumab for treatment of recurrent glioblastoma (rGBM). ASC40 is an oral, sele...
Ascletis Announces Signing of Ritonavir Tablet Purchase Agreement with Phokam Pharmaceutical Import-Export Co., Ltd of Laos
HANGZHOU and SHAOXING, China, Jan. 18, 2022 /PRNewswire/ -- Ascletis Pharma Inc. ("Ascletis") (HKEX: 1672) today announces signing of the ritonavir tablet purchase agreement between Phokam Pharmaceutical Import-Export Co., Ltd (as buyer) ofLaos and Ascletis Pharmaceuticals Co., Ltd. (as seller), ...
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...
