- Evaluate the disappearance of hepatitis B surface antigen in 44 patients who completed 24 weeks of treatment with 1 mg/kg ASC22 (n=33) or placebo (n=11) combined with nucleoside (acid) analogs
- Of the 33 patients treated with ASC22, 16 had hepatitis B surface antigen ≤ 500 IU/mL at baseline, and 19% (3/16) of the patients achieved hepatitis B surface antigen disappearance after ASC22 treatment, and after ASC22 was discontinued There was no rebound, indicating a functional cure for hepatitis B
Hangzhou and Shaoxing, China, November 9th, 2021/PRNewswire/ - Golly Pharmaceuticals Co.
(Hong Kong Stock Exchange code: 1672) today announced that according to its subcutaneous injection of PD-L1 antibody ASC22 (Envolimab) IIb In the interim results of 44 patients in the phase clinical trial (Clinical Trial No.
: NCT04465890), persistent hepatitis B surface antigen disappearance can be observed in patients with baseline hepatitis B surface antigen ≤ 500 IU/mL
The abstract formed by the results was selected as the latest research abstract at the 2021 American Association for the Study of Liver Diseases (AASLD) Annual Meeting (The Liver Meeting® 2021) and made an oral report
According to the selection criteria of the American Association for the Study of Liver Diseases (AASLD) annual meeting, the latest research abstract must be a research result of high scientific importance and influence
The Phase IIb trial is a randomized, single-blind, placebo-controlled, multi-center Chinese clinical trial to evaluate 1 mg/kg, 2.
5 mg/kg ASC22 in patients with chronic hepatitis B every 2 weeks for 24 weeks Or placebo combined with the safety and effectiveness of nucleoside (acid) analogs
"ASC22 is the world's earliest and fastest-growing clinical study for functional cure of hepatitis B (ie, the disappearance of hepatitis B surface antigen) by blocking the PD-1/PD-L1 signaling pathway.
It was selected as the latest research abstract and made an oral report.
The organizing committee of the conference is paying attention to this research
" Professor Wang Guiqiang, the main investigator of the ASC22 Phase IIb clinical trial, the chairman of the 11th Committee of the Infectious Diseases Branch of the Chinese Medical Association, and the director of the Department of Infectious Diseases and Liver Diseases Center of Peking University First Hospital, said
"Scientists all over the world are making unremitting efforts to cure hepatitis B, but the disappearance of hepatitis B antigen is difficult to achieve
We are very excited to see that ASC22 as an immunotherapy has laid the foundation for the functional cure of hepatitis B.
About 30% of the nucleoside The surface antigen concentration of chronic hepatitis B patients treated with drugs is less than 500 IU/mL.
Based on the above-mentioned exciting interim data, we will advance the follow-up registration trials as planned
” said Dr.
Wu Jinzi, founder, chairman of the board of directors and CEO of Geli
The summary information of the report is as follows:
HBsAg LOSS IN CHRONIC HEPATITIS B PATIENTS WITH SUBCUTANEOUS PD-L1 ANTIBODY ASC22 (ENVAFOLIMAB) PLUS NUCLEOS(T)IDE ANALOGS TREATMENT: INTERIM RESULTS FROM A PHASE IIb CLINICAL TRIAL
Report format: Parallel session, oral report abstract number: LO12 Conference theme: latest abstract Session 2 Speaker: Dr.
Wu Jinzi, Golly Biotechnology (Hangzhou) Co.
Reporting time: Monday, November 15, 2021, Eastern Standard Time , 12:30-02:00 pm
Gale is an innovative R&D-driven biotechnology company listed on the Hong Kong Stock Exchange (1672.
HK), covering the complete value chain from new drug discovery and development to production and commercialization
Gale is committed to the development and commercialization of innovative drugs in the fields of viral diseases, non-alcoholic steatohepatitis/primary biliary cholangitis, tumors (oral tumor metabolic checkpoints and immune checkpoint inhibitors) to solve domestic problems.
Clinical needs of foreign patients
Under the leadership of a management team with deep professional knowledge and outstanding past achievements, Gallé lays out the field of innovative drug research and development with a global perspective, aims at unmet clinical needs, and is positioned as an international leader in research and development, and promotes efficiently and quickly.
Development of pipeline products
Gale currently has three commercialized products and 18 strong and innovative R&D pipelines.
Many of the pipelines in research are in an internationally leading position and are actively deploying new therapeutic areas:
Viral diseases: (1) Hepatitis B (functional cure): Explore a treatment plan that uses subcutaneous injection of PD-L1 antibody ASC22 and PEGASYS® as cornerstone drugs, combined with other target drugs, and is expected to be a functional cure for hepatitis B Bring a major breakthrough
(2) AIDS: immunotherapy ASC22, used for AIDS-specific immune reconstruction, in order to achieve functional cure for AIDS-infected patients
(3) Hepatitis C: Golly successfully developed and marketed a full oral hepatitis C treatment plan consisting of two new class 1 drugs, Ganovo® and Xinlilai®
Non-alcoholic steatohepatitis/primary biliary cholangitis: Gan Lai Pharmaceutical, a wholly-owned subsidiary of Golly, focuses on the development and commercialization of innovative drugs in the field of non-alcoholic steatohepatitis
Gan Lai Pharmaceutical has three clinical stage non-alcoholic steatohepatitis drug candidates for fatty acid synthase (FASN), thyroid hormone ß receptor (THRß) and farnesol X receptor (FXR) and three fixed doses Compound preparations
New drugs targeting the FXR target are also being developed for the treatment of primary biliary cholangitis
Oncology (oral tumor metabolism checkpoints and immune checkpoint inhibitors): Golly has an innovative and differentiated pipeline in the field of tumor treatment, focusing on oral fatty acid synthase inhibitors that play a key role in tumor lipid metabolism Pipeline and a new generation of immune checkpoint inhibitors-oral PD-L1 small molecule inhibitor pipeline
Expanding indications: acne: ASC40 has been approved to enter Phase II clinical trials for new acne indications following non-alcoholic steatohepatitis and solid tumor indications
Source: Golly Pharmaceutical Co.