HongKong:1672

Ascletis Announces U.S. FDA Approval of Conducting a Phase IIa Clinical Trial for ASC10 to Treat Respiratory Syncytial Virus Infection

--Respiratory syncytial virus (RSV) infection treatment remains huge unmet medical needs and there is no effective drug for treatment globally so far --Dosage of 800 mg ASC10, twice daily was selected to conduct a Phase IIa study in patients with RSV infection --Preclinical research showed t...

2023-01-31 17:40 1131

Ascletis Announces IND Approval of Oral Viral Polymerase Inhibitor ASC10 for Monkeypox Indication by China NMPA

--Preclinical studies show that ASC10-A, the active metabolite of double prodrug ASC10, has potent antiviral activities against both monkeypox and SARS-CoV-2 viruses --Ascletis has received the Notice of Issuance from the United States Patent and Trademark Office (USPTO) for the patent applicati...

2023-01-26 21:08 2015

Ascletis Announces Entering into a Supply Agreement of Ritonavir Tablets with Simcere

HANGZHOU and SHAOXING, China, Jan. 17, 2023 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") today announces that its wholly owned subsidiary Ascletis Pharmaceuticals Co., Ltd. has entered into a supply agreement of ritonavir tablets with Hainan Simcere Pharmaceutical Co., Ltd., a su...

2023-01-17 08:29 1513

Ascletis Announces Dosing of 4 Healthy Subjects of the First Cohort in Multiple-Dose Escalation Phase I Clinical Trial of Oral 3CLpro Inhibitor ASC11 for COVID-19

--The multiple-dose escalation Phase I clinical trial is expected to enroll 72 healthy subjects, and the enrollment is expected to be completed in the first quarter of 2023 --Ascletis has filed global patent applications for ASC11 and related compounds and their use in viral disease HANGZHOU an...

2023-01-16 08:10 1617

Ascletis Believes that the Complaints Made by Viking Therapeutics Have No Merit and will Vigorously Defend Against such Complaints

HANGZHOU and SHAOXING, China, Jan. 2, 2023 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") was recently informed that onDecember 29, 2022, Viking Therapeutics, Inc. ("Viking"), a pharmaceutical company inthe United States, filed certain complaints against Ascletis, its founder Dr. J...

2023-01-02 19:24 746

Ascletis' NASH Drug ASC41(THRβ) Phase II Enrollment is Progressing as Planned

HANGZHOU and SHAOXING, China, Dec. 21, 2022 /PRNewswire/ -- The enrollment of the 52-week Phase II clinical trial of thyroid hormone receptor β (THRβ) agonist ASC41 developed in house by Gannex Pharma Co., Ltd., a wholly owned subsidiary of Ascletis Pharma Inc. (HKEX: 1672, "Ascletis"), for tr...

2022-12-21 08:00 1669

Ascletis Announces Notice of Issuance of the U.S. Patent for Oral Viral Polymerase Inhibitor ASC10 and Its Derivatives

--The issue date of the patent will be January 3, 2023 by the United States Patent and Trademark Office (USPTO). The patent number is 11,541,071 -- The issued patent covers ASC10 and its derivatives, and their uses to treat virus infections including SARS-CoV-2, monkeypox virus and respiratory s...

2022-12-19 18:10 1241

Ascletis Announces Positive Phase I Clinical Results of Oral RdRp Inhibitor ASC10 for COVID-19

--The exposure of active drug ASC10-A after twice daily dosing 800 mg double prodrug ASC10 in Chinese subjects was 94% of that after twice daily dosing 800 mg single prodrug molnupiravir in Japanese subjects --Based on Ascletis' Phase I results of ASC10 and molnupiravir's clinical efficacy data ...

2022-12-12 23:29 3064

Ascletis Announces IND Approval of Oral 3CLpro Inhibitor ASC11 for COVID-19 by China NMPA

--The objective of Phase I clinical trial is to identify a safe and efficacious dose for the pivotal Phase II/III in COVID-19 patients. Phase I clinical trial is expected to be completed within the first quarter of 2023 --Phase I clinical trial will also determine if ASC11 needs to be boosted by ...

2022-12-07 18:10 2112

Ascletis Announces Completion of 180 Patient Enrollment for Phase II Clinical Trial of FASN Inhibitor ASC40 for Acne

--To date, approximately 50% enrolled patients have completed 12-week treatment and all enrolled patients are expected to complete 12-week treatment by the end ofFebruary 2023 -- Clinical efficacy observed in patients who have completed 12-week treatment of ASC40 or placebo was comparable t...

2022-11-30 20:41 1282

Ascletis Announces Completion of 180 Patient Enrollment for Phase II Clinical Trial of FASN Inhibitor ASC40 for Acne

--To date, approximately 50% enrolled patients have completed 12-week treatment and all enrolled patients are expected to complete 12-week treatment by the end ofFebruary 2023 -- Clinical efficacy observed in patients who have completed 12-week treatment of ASC40 or placebo was comparable t...

2022-11-30 20:39 960

Ascletis Announces IND Filing of Oral 3CLpro Inhibitor ASC11 for COVID-19 Accepted by China NMPA

HANGZHOU, China and SHAOXING, China, Nov. 29, 2022 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that the Investigational New Drug (IND) application of ASC11, an oral inhibitor drug candidate targeting 3-chymotrypsin like protease (3CLpro) for COVID-19, has been ac...

2022-11-29 08:10 2916

Ascletis Announces IND Approval of Oral 3CLpro Inhibitor ASC11 for COVID-19 by U.S. FDA

--The Phase I clinical trial will consist of 3 cohorts in healthy subjects, including single- and multiple-dose escalation studies and food effect study. The objective of Phase I trial is to find a right dose to move into the pivotal Phase II/III in COVID-19 patients --In antiviral cellular assa...

2022-11-23 19:43 2886

Ascletis Announces IND Approval of Oral PD-L1 Small Molecule Inhibitor ASC61 for Treatment of Advanced Solid Tumors by China NMPA

--While the ASC61 Phase I study is ongoing in the U.S., the Investigational New Drug (IND) approval inChina will accelerate the global development of ASC61, an in-house developed oral PD-L1 small molecule inhibitor HANGZHOU and SHAOXING, China, Nov. 17, 2022 /PRNewswire/ -- Ascletis Pharma Inc. ...

2022-11-17 08:10 2935

Ascletis Announces IND Approval of Viral Polymerase Inhibitor ASC10 for Monkeypox Indication by U.S. FDA

--Based on available data, ASC10 at the dosage of 800 mg twice daily was approved by the U.S. Food and Drug Administration (FDA) to conduct a Phase Ib study in patients with monkeypox virus disease --Preclinical studies show that ASC10-A, active metabolite of double prodrug ASC10, has potent ant...

2022-11-16 08:10 1835

Ascletis Announces Poster Presentation of Phase I, Single-Dose Study of ASC43F for NASH at AASLD Annual Meeting 2022

HANGZHOU and SHAOXING, China, Nov. 7, 2022 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX:1672, "Ascletis") announces today that the abstract of a Phase I, Single-Dose Study of ASC43F for non-alcoholic steatohepatitis (NASH) has been reported at The Liver Meeting® 2022 of the American Association for...

2022-11-07 08:10 1344

Ascletis Announces U.S. IND Filing of Oral 3CLpro Inhibitor ASC11 for COVID-19

-- ASC11 is an in-house discovered oral small molecule drug candidate, targeting 3-chymotrypsin like protease (3CLpro) -- In antiviral cellular assays with infectious SARS-CoV-2, ASC11 demonstrated higher potency against SARS-CoV-2 than other 3CLpro inhibitors including Nirmatrelvir, S-217622, P...

2022-11-02 08:10 1477

Ascletis Announces U.S. IND Filing of Oral Antiviral ASC10 for Monkeypox Indication

--ASC10 has two indications: monkeypox and SARS-CoV-2 virus infections. The Investigational New Drug (IND) application of the latter was approved by the U.S. Food and Drug Administration (FDA) inAugust 2022 and Phase Ib clinical trial in COVID-19 patients is underway in the U.S. --Preclinical st...

2022-10-26 20:10 1707

Ascletis Announces Dosing of 24 Healthy Subjects of the First 3 Cohorts in Multiple-Dose Escalation Phase I Clinical Trial of Oral RdRp Inhibitor ASC10 for COVID-19

--The multiple-dose escalation Phase I clinical trial will enroll 72 healthy subjects including 60 subjects in 6 dose escalation cohorts and 12 subjects in food effect trial. The enrollment is expected to be completed in the fourth quarter of 2022 --ASC10 is an oral double prodrug. After oral ...

2022-10-10 08:10 1207

Ascletis Announces Dosing of the First Patient in Phase II Clinical Trial of THRβ Agonist ASC41 for 52-Week Treatment of Liver Biopsy-Proven NASH

-- ASC41 is ranking first in China and third in the world in terms of clinical progress as a thyroid hormone receptor β (THRβ) agonist drug candidate for non-alcoholic steatohepatitis (NASH).  ASC41 Phase II clinical trial is currently the most advanced 52-week Phase II clinical trial which is in...

2022-10-05 08:10 1724
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