Gannex

Gannex Published Phase I Data of ASC42, a Novel Farnesoid X Receptor Agonist on the Journal Drugs in R&D

Retrieved on: 
Monday, November 6, 2023
TC, PD, UDCA, Hepatology, Ursodeoxycholic acid, AST, Primary biliary cholangitis, PBC, Pharmacokinetics, Phase, American Association for Geriatric Psychiatry, NASH, GGT, Medicine, Non-alcoholic fatty liver disease, FXR, NAFLD, Obeticholic acid, Safety, ALT, Patient, OCA, Diagnosis, FGF19, New England, Pharmaceutical industry, Gannex

In-house developed by Gannex, ASC42 is a novel non-steroidal, selective, potent FXR agonist with best-in-class potential and global intellectual property.

Key Points: 
  • In-house developed by Gannex, ASC42 is a novel non-steroidal, selective, potent FXR agonist with best-in-class potential and global intellectual property.
  • On July 20, 2023, Gannex announced the completion of patient enrollment for Phase II clinical trial of ASC42 for PBC.
  • The Phase II clinical trial of Gannex's in-house developed farnesoid X receptor agonist ASC42 will be completed soon.
  • The topline data of the Phase II clinical trial are expected to be released by the end of 2023.

Ascletis Announces Cooperation with China Meheco International Co., Ltd. in Distribution of Its Ritonavir Tablets in Chinese Mainland

Retrieved on: 
Wednesday, April 13, 2022
Pegasys, COVID-19, PD-L1, HCV, Hepatitis B virus, HIV/AIDS, Patient, Distribution, Cornerstone, Danoprevir, Infection, THR, FASN, National Medical Products Administration, Gannex, Health, Hepatitis C, GBM, HKEX, Insurance, RNA, Occupational Safety and Health Act 1994, PBC, Hong Kong Stock Exchange, Medication, Shanghai Stock Exchange, CEO, WHO Disease Staging System for HIV Infection and Disease in Adults and Adolescents, NASH, R, OBI Pharma, Inc., Degenerative disease, United Kingdom, CHB, Acne, RNA polymerase II, Chinese Communist Party Committee Secretary, Ritonavir, AIDS, Ravidasvir, FXR, Generic drug, Vaccine, Pharmaceutical industry, Cancer

HANGZHOU, China and SHAOXING, China, April 13, 2022 /PRNewswire/ --Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") today announces that Ascletis Pharmaceuticals Co., Ltd. ("Ascletis Pharmaceuticals") has signed an agreement with China Meheco International Co., Ltd. for distribution of its ritonavir tablets in Chinese mainland.

Key Points: 
  • HANGZHOU, China and SHAOXING, China, April 13, 2022 /PRNewswire/ --Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") today announces that Ascletis Pharmaceuticals Co., Ltd. ("Ascletis Pharmaceuticals") has signed an agreement with China Meheco International Co., Ltd. for distribution of its ritonavir tablets in Chinese mainland.
  • Ascletis Pharmaceuticals is a wholly-owned subsidiary of Ascletis, and China Meheco International Co., Ltd. is a wholly-owned subsidiary of China Meheco Group Co., Ltd. ("China Meheco").
  • By this opportunity, we hope to explore various levels of cooperation with biotech companies in China such as Ascletis.
  • Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis, said, "It's a great honor to cooperate with China Meheco in commercialization of ritonavir tablets.

Ascletis Announces the Latest Results of the Preclinical Studies of Two Novel Anti-Cancer Drug Candidates, ASC61 and ASC60, to be presented at AACR Annual Meeting 2022

Retrieved on: 
Sunday, March 27, 2022
Pegasys, Company, Cornerstone, Hepatitis B virus, Syngenic, Metabolism, Center for Drug Evaluation and Research, Mass flow (life sciences), CHB, National Medical Products Administration, Acne, Compliance, GBM, AACR, Gannex, Research, Mab, CEO, RNA, Food, NMPA, PD-1, RNA polymerase II, PBC, FXR, NASH, Center, HIV/AIDS, WHO Disease Staging System for HIV Infection and Disease in Adults and Adolescents, FASN, COVID-19, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, DNL, Hepatitis C, Degenerative disease, THR, R, De novo, CDE, FDA, Bevacizumab, PD-L1, Patient, Phase, Hong Kong Stock Exchange, Pharmaceutical industry, Vaccine, Cancer

Preclinical studies showed that ASC61 demonstrated significant antitumor efficacies and were well-tolerated in both syngeneic and humanized tumor mouse models.

Key Points: 
  • Preclinical studies showed that ASC61 demonstrated significant antitumor efficacies and were well-tolerated in both syngeneic and humanized tumor mouse models.
  • ASC61 was found to have favorably comparable antitumor activities as the U.S. Food and Drug Administration (FDA) approved PD-L1 therapeutic monoclonal antibody (mAb), Atezolizumab.
  • ASC60 can disrupt metabolism and tumor-associated signal transduction in tumor cells through inhibition of de novo lipogenesis (DNL).
  • Preclinical studies showed that ASC60 could suppress tumor growth and enhance the antitumor activities of mPD-1 antibody in tumor mouse models.

Ascletis Announces Submission of Marketing Authorization Applications for Ritonavir in Eight Additional European Countries

Retrieved on: 
Tuesday, March 1, 2022
HIV/AIDS, Hepatitis B virus, Ritonavir, Hepatitis C, Hong Kong Stock Exchange, RNA, GBM, National Medical Products Administration, Cornerstone, Pegasys, FXR, THR, COVID-19, HKEX, CHB, WHO Disease Staging System for HIV Infection and Disease in Adults and Adolescents, PBC, Tablet, PD-L1, FASN, AbbVie, Cancer, Acne, R, Patient, Gannex, NASH, RNA polymerase II, Degenerative disease, Animal, Pharmaceutical industry, Vaccine

HANGZHOU, China and SHAOXING, China, March 1, 2022 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672) today announces that it has submitted marketing authorization applications for ritonavir (100 mg film-coated tablet) in eight additional European countries (Spain, Portugal, Italy, Belgium, Poland, Sweden, the Netherlands and Denmark) through its agent in Europe.

Key Points: 
  • In addition to the above eight European countries, Ascletis had submitted ritonavir marketing authorization applications in Germany, France, Ireland and United Kingdom.
  • It is expected that more marketing authorization applications for ritonavir in other regions, including Euro-Asia, North & South America, Africa and Asian Pacific, will soon be submitted by Ascletis.
  • Ascletis continues the engagement with both domestic and major multi-national pharmaceutical companies, for the commercial supplies of ritonavir within China and globally.
  • Ascletis aims to be one of the global commercial suppliers of oral ritonavir tablets.

Ascletis Announces Submission of Marketing Authorization Applications for Ritonavir in Multiple European Countries

Retrieved on: 
Sunday, February 13, 2022
Tablet, WHO Disease Staging System for HIV Infection and Disease in Adults and Adolescents, Pegasys, Patient, Cancer, National Medical Products Administration, Ritonavir, RNA polymerase II, FXR, Cornerstone, RNA, PD-L1, R, HKEX, OBI Pharma, Inc., FASN, Hepatitis B virus, NASH, Acne, THR, AbbVie, Solubility, Degenerative disease, CHB, PBC, Hepatitis C, GBM, HIV/AIDS, COVID-19, Gannex, Hong Kong Stock Exchange, Pharmaceutical industry, Vaccine

It is expected that more marketing authorization applications for ritonavir in certain other countries, including the ones in Europe, North America and Asian Pacific will soon be submitted.

Key Points: 
  • It is expected that more marketing authorization applications for ritonavir in certain other countries, including the ones in Europe, North America and Asian Pacific will soon be submitted.
  • Ascletis aims to be one of the global commercial suppliers of oral ritonavir tablets.
  • Ascletis owns the only authorized oral ritonavir tablet in China, which passed bioequivalence study.
  • Ascletis' oral ritonavir tablet was approved in September 2021 by China National Medical Products Administration (H20213698).

Ascletis Announces U.S. IND Approval of Oral PD-L1 Small Molecule Inhibitor ASC61 for Treatment of Advanced Solid Tumors

Retrieved on: 
Sunday, February 6, 2022
RNA, Hong Kong Stock Exchange, Gannex, Acne, CHB, HIV/AIDS, Injection, Hepatitis, HKEX, III, FXR, Degenerative disease, NASH, PD-1, Cancer, IND, GBM, Clinical trial, PD-L1, Hepatitis B virus, FDA, Patient, Food and Drug Administration, RNA polymerase II, Investigational New Drug, Safety, Ira Pastan, Bevacizumab, Hepatitis C, Cornerstone, Mass flow (life sciences), R, Pegasys, CEO, PBC, Tablet, THR, Food, FASN, WHO Disease Staging System for HIV Infection and Disease in Adults and Adolescents, COVID-19, Pharmaceutical industry, Vaccine

This is Ascletis' second U.S. IND approval in 2022 after ASC22 (Envafolimab) U.S. IND approval for functional cure of chronic hepatitis B (CHB).

Key Points: 
  • This is Ascletis' second U.S. IND approval in 2022 after ASC22 (Envafolimab) U.S. IND approval for functional cure of chronic hepatitis B (CHB).
  • The ASC61 Phase I trial in the U.S. is a dose escalation study in patients with advanced solid tumors.
  • The objectives of such study are to find a recommended Phase II dose (RP2D) and obtain preliminary efficacy in patients with advanced solid tumors.
  • ASC61 is an oral potent and highly selective PD-L1 small molecule inhibitor and blocks PD-1/PD-L1 interaction through inducing PD-L1 dimerization and internalization.

Ascletis Announces U.S. IND Approval of ASC22 (Envafolimab), a Subcutaneously Administered PD-L1 Antibody for Functional Cure of Chronic Hepatitis B

Retrieved on: 
Monday, January 17, 2022
Research, Gannex, Liver cancer, HKEX, Cornerstone, Acne, CHB, Investigational New Drug, Prevalence, PD-1, RNA, COVID-19, GBM, Safety, Hong Kong Stock Exchange, NASH, Hepatitis B, Nas, CDC classification system for HIV infection, Hepatitis C, WHO, OBI Pharma, Inc., FXR, Doctor of Philosophy, HBsAg, Food, World Health Organization, Phase, Interim, FDA, Patient, Institute of Liver and Biliary Sciences, World, Association, HBV, IIB, DHHS, American Association, Pegasys, R, American Association for Cancer Research, AASLD, RNA polymerase II, CEO, Degenerative disease, IND, Hepatitis B virus, HIV/AIDS, FASN, PBC, Food and Drug Administration, PD-L1, THR, United States Department of Health and Human Services, Vaccine, Pharmaceutical industry, Medical device, Cancer

HANGZHOU and SHAOXING, China, Jan. 17, 2022 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672) announces today the Investigational New Drug (IND) application approval by U.S. Food and Drug Administration (FDA) and initiation of global development of ASC22 (Envafolimab), a first-in-class, subcutaneously administered PD-L1 antibody for functional cure of chronic hepatitis B (CHB).

Key Points: 
  • Such inclusion is a singular honor and indicates the high level with which the AASLD review committee regards Ascletis' research in CHB functional cure.
  • "ASC22 (Envafolimab) U.S. IND approval enables us to initiate U.S. and global clinical trials for CHB functional cure.
  • Viral Diseases: (1) Hepatitis B Virus (functional cure): focus on breakthrough therapies for CHB functional cure with a subcutaneously-injected PD-L1 antibody ASC22 and Pegasys as cornerstone drugs.
  • (3) HIV/AIDS: ASC22, an immune therapy to restore HIV-specific immune responses and eventually lead to a functional cure of HIV-infected patients.

Ascletis Announces U.S. IND Approval of ASC22 (Envafolimab), a Subcutaneously Administered PD-L1 Antibody for Functional Cure of Chronic Hepatitis B

Retrieved on: 
Monday, January 17, 2022
Research, Gannex, Liver cancer, HKEX, Cornerstone, Acne, CHB, Investigational New Drug, Prevalence, PD-1, RNA, COVID-19, GBM, Safety, Hong Kong Stock Exchange, NASH, Nas, WHO Disease Staging System for HIV Infection and Disease in Adults and Adolescents, Hepatitis C, WHO, OBI Pharma, Inc., FXR, Doctor of Philosophy, HBsAg, Food, World Health Organization, Interim, FDA, Patient, Institute of Liver and Biliary Sciences, World, Association, HBV, IIB, DHHS, American Association, Pegasys, R, American Association for Cancer Research, AASLD, RNA polymerase II, CEO, Degenerative disease, IND, Hepatitis B virus, HIV/AIDS, FASN, PBC, Food and Drug Administration, PD-L1, THR, United States Department of Health and Human Services, Pharmaceutical industry, Vaccine, Medical device, Cancer

Such inclusion is a singular honor and indicates the high level with which the AASLD review committee regards Ascletis' research in CHB functional cure.

Key Points: 
  • Such inclusion is a singular honor and indicates the high level with which the AASLD review committee regards Ascletis' research in CHB functional cure.
  • "ASC22 (Envafolimab) U.S. IND approval enables us to initiate U.S. and global clinical trials for CHB functional cure.
  • Viral Diseases: (1) Hepatitis B Virus (functional cure): focus on breakthrough therapies for CHB functional cure with a subcutaneously-injected PD-L1 antibody ASC22 and Pegasys as cornerstone drugs.
  • (3) HIV/AIDS: ASC22, an immune therapy to restore HIV-specific immune responses and eventually lead to a functional cure of HIV-infected patients.

Ascletis Announces Inclusion in New Catalogue of China National Reimbursement Drug List (NRDL) of ASCLEVIR®/ GANOVO® Regimen, an All-oral Direct Anti-HCV Therapy

Retrieved on: 
Friday, December 3, 2021
Patient, National Science Board, Cornerstone, CEO, Pegasys, Safety, PD-L1, FASN, Drug, CDC classification system for HIV infection, HKEX, CHB, GBM, Hong Kong Stock Exchange, Occupational Safety and Health Act 1994, Program, Danoprevir, Disease, HCV, National Healthcare, Guideline, Gannex, Degenerative disease, National Healthcare Security Administration, FXR, Cirrhosis, Liver cancer, Hepatitis B virus, PBC, Treatment, Management process, Insurance, Phase, Acne, HIV/AIDS, Conditional sentence, Infection, R, NASH, Hepatitis C, Public health, Mortality, Ravidasvir, Hospital, NRDL, Viral hepatitis, THR, Pharmaceutical industry, Vaccine

HANGZHOU, China and SHAOXING, China, Dec. 2, 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 Insurance, Work-Related Injury Insurance and Maternity Insurance (2021) (《国家基本医疗保险、工伤保险和生育保险药品目录（2021）年》) (the "National Reimbursement Drug List" or the "NRDL"). 

Key Points: 
  • The results from the Phase II/III clinical trials in China with the all-oral direct anti-HCV ASCLEVIR / GANOVO regimen showed a 99% cure rate in genotype 1 non-cirrhosis HCV patients.
  • ASCLEVIR is a pan-genotypic NS5Ainhibitor with high genetic barrier to resistance, with a cure rate of 100% in patients with baseline NS5Aresistance.
  • "The assessment by National Healthcare Security Administration ("NHSA") is based on multi-factors including efficacy, safety, economy, novelty and fairness.
  • Ascletis will continue to support the country's healthcare system and contributes to the national 'Healthy China' strategy."

Ascletis Announces Approval of Phase II Clinical Trial of ASC22 (Envafolimab) by China NMPA for Immune Restoration/Functional Cure of HIV-1 Infected Patients

Retrieved on: 
Wednesday, November 10, 2021
Phase, Safety, Immunity, Hong Kong Stock Exchange, PD-L1, CDC classification system for HIV infection, HIV/AIDS, CHB, Viremia, R, Cornerstone, Hepatitis C, Hepatitis, CEO, HIV, Gannex, FXR, GBM, FASN, PD-1, HIV-1, National Medical Products Administration, PBC, OBI Pharma, Inc., NASH, Degenerative disease, Hepatitis B virus, Antibody, Cart, Infection, Acne, HKEX, THR, Patient, Death, NMPA, Pegasys, Pharmaceutical industry, Vaccine

HANGZHOU, Chinaand SHAOXING, China, Nov. 9, 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/functional cure of human immunodeficiency virus 1 (HIV-1) infected patients.

Key Points: 
  • HANGZHOU, Chinaand SHAOXING, China, Nov. 9, 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/functional cure of human immunodeficiency virus 1 (HIV-1) infected patients.
  • Immune restoration/functional cure in HIV-1 infected patients is the second indication of ASC22 developed by Ascletis, in addition to functional cure of chronic hepatitis B (CHB) patients.
  • (2) HIV/AIDS: ASC22, an immune therapy to restore HIV-specific immune responses and eventually lead to a functional cure of HIV-infected patients.
  • Exploratory Indications: Acne: Following NASH and recurrent GBM, the third indication for ASC40 has been approved to enter Phase 2 clinical trial.