WHO Disease Staging System for HIV Infection and Disease in Adults and Adolescents

Mereo BioPharma announces Positive Top-Line Efficacy and Safety Data from “ASTRAEUS” Phase 2 Trial of Alvelestat in Alpha-1 Antitrypsin Deficiency-associated Emphysema

Retrieved on: 
Monday, May 9, 2022

LONDON and REDWOOD CITY, Calif., May 09, 2022 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO), (“Mereo” or “the Company”), a clinical-stage biopharmaceutical company focused on oncology and rare diseases, today announced positive top-line efficacy and safety results from “ASTRAEUS” a Phase 2 study of the investigational oral neutrophil elastase (NE) inhibitor, alvelestat (MPH-966), in patients with severe alpha-1 antitrypsin deficiency-associated emphysema.

Key Points: 
  • Consistent with the known safety profile of alvelestat, no safety signals were observed in adverse event (AE) monitoring.
  • Most AEs were mild to moderate, including within Adverse Events of Special Interest (AESI) which were observed in 23 subjects.
  • Prior to Mereo BioPharma licensing alvelestat from AstraZeneca (AZ), trials across COPD, bronchiectasis and cystic fibrosis (CF) had been performed.
  • Mereo reported a positive Phase 1b/2 trial in COVID-19 which was completed in 2021 and showed alvelestat was safe and well tolerated.

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

Retrieved on: 
Wednesday, April 13, 2022

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.

Mereo BioPharma Reports Full Year 2021 Financial Results and Recent Highlights

Retrieved on: 
Thursday, March 31, 2022

LONDON and REDWOOD CITY, Calif., March 31, 2022 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO) (Mereo or the Company), a clinical-stage biopharmaceutical company focused on oncology and rare diseases, today announced financial results for the year ended December 31, 2021 and provided an update on recent corporate highlights.

Key Points: 
  • LONDON and REDWOOD CITY, Calif., March 31, 2022 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO) (Mereo or the Company), a clinical-stage biopharmaceutical company focused on oncology and rare diseases, today announced financial results for the year ended December 31, 2021 and provided an update on recent corporate highlights.
  • During 2021, we continued to execute on all fronts and made substantial progress across our pipeline.
  • Following our accomplishments in 2021, we look forward to our upcoming catalysts in 2022.
  • Full year 2021 research and development expenses were23.6 million, compared to16.3 millionin 2020, an increase of 7.2 million, or 44%.

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

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

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

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

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

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.

Gannex Announces U.S. IND Approval of ASC43F, a First-in-Class Dual-Target Fixed-Dose Combination for NASH

Retrieved on: 
Monday, November 1, 2021

Dr. Handan He, Chief Scientific Officer of Ascletis, stated, "NASH is a metabolic syndrome with a complex underlying pathophysiology.

Key Points: 
  • Dr. Handan He, Chief Scientific Officer of Ascletis, stated, "NASH is a metabolic syndrome with a complex underlying pathophysiology.
  • Thus, combination treatments with different mechanisms of action and/or different targets is a promising approach to combat this liver disease.
  • NASH: Gannex, a wholly-owned company of Ascletis, is dedicated to the R&D and commercialization of new drugs in the field of NASH.
  • (3) HIV/AIDS: ASC22, an immune therapy to restore HIV-specific immune responses and eventually lead to a functional cure of HIV-infected patients.

Lilly to Unveil New Data at the Annual European Congress of Rheumatology, Furthering Commitment to Scientific Discovery in Immunology

Retrieved on: 
Monday, June 11, 2018

"We are excited to be sharing data evaluating baricitinib as a potential treatment for systemic lupus erythematosus, underscoring the potential of our immunology portfolio."

Key Points: 
  • "We are excited to be sharing data evaluating baricitinib as a potential treatment for systemic lupus erythematosus, underscoring the potential of our immunology portfolio."
  • Carefully consider the risks and benefits of OLUMIANT prior to initiating therapy in patients with chronic or recurrent infection.
  • Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with OLUMIANT.
  • Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world.