SHANGHAI, April 19, 2024 /PRNewswire/ — GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, announced US Food and Drug Administration (FDA) has granted the clinical trial approval for GFH925 (KRAS G12C inhibitor) in a multi-center, open-label, randomized and controlled phase III study treating refractory metastatic colorectal cancer (CRC) patients. It is the first phase III trial of KRAS G12C inhibitor monotherapy targeting CRC patients worldwide, with GFH925 being the first G12C inhibitor that received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for previously treated advanced CRC. GFH925 was also granted BTD and New Drug Application acceptance with Priority Review Designation by NMPA for previously treated advanced non-small cell lung cancer(NSCLC)patients with G12C mutation. The trial (GFH925X0301) will enroll refractory metastatic CRC patients harboring KRAS G12C mutation who have progressed or experienced disease recurrence on or after at least two prior ...
SHANGHAI, March 26, 2024 /PRNewswire/ — BioDuro-Sundia’s partner, DigmBio, a South Korean biotechnology company, announced its selective PARP1 inhibitor for the treatment of triple-negative breast cancer has been approved by Korea Food and Drug Administration (MFDS) for Investigational New Drug (IND) application. Founded in April 2020, DigmBio is a pioneering biotech company discovering and developing novel therapies to treat oncology, neurodegeneration, and fibrosis. The lead program DM5167 is the 2nd generation PARP1 selective inhibitor. According to preclinical study results, DM5167, a novel selective PARP1 inhibitor, exhibits superior in vivo safety, particularly in terms of hematotoxicity and demonstrates enhanced selectivity in enzyme assays, and possesses a more efficient DNA trapping capability. Notably, DM5167 showcases excellent brain permeability, rendering it suitable for treating brain metastasis and brain cancer. DigmBio CEO Kim Jung-min stated, “We are pleased to receive official approval from the Food and Drug Safety Department without the need for any ...
Recently, Hengrui Pharmaceuticals and its subsidiaries Suzhou Shengdia Biopharmaceutical Co., Ltd. and Chengdu Shengdi Pharmaceutical Co., Ltd. received the Notice of Approval for Drug Clinical Trial approved for issuance by the State Drug Administration, which authorizes the conduct of a clinical trial of HRS-1167 tablets (Merck code: M9466) in combination with injectable SHR-A1921 or in combination with bevacizumab or in combination with abiraterone acetate tablets (I) and Prednisone/Prednisolone (AA-P) for advanced solid tumors in a Phase Ib/II clinical study. In October 2023, Hengrui Pharmaceuticals entered into a strategic cooperation with Merck KGaA of Germany, which obtained the exclusive rights to develop, manufacture and commercialize HRS-1167 (M9466) globally outside of mainland China, which was the first time that Hengrui Pharmaceuticals entered into a strategic cooperation with a large global multinational enterprise. Poly (ADP-ribose) polymerase (PARP) is a class of multifunctional protein post-translational modification enzymes widely found in eukaryotic cells, and plays ...
The annual meeting of the American Association for Cancer Research (AACR) will be held on April 5-10, 2024 local time in San Diego, USA. At the meeting, Yifang Bio will present the latest results from the Phase II clinical trial of garsorasib (D-1553) in patients with non-small cell lung cancer (NSCLC) with KRAS G12C mutation. This will mark the study’s (NCT05383898) appearance at a prestigious international academic conference following the World Conference on Lung Cancer (WCLC) 2022. About Garsorasib KRAS mutations are widespread in several highly lethal cancer types, with KRAS G12C being a specific KRAS mutation that accounts for approximately 44% of all KRAS mutations.KRAS G12C mutations are more common in lung, colorectal, pancreatic, and bile duct cancers. According to Frost & Sullivan, from 2016 to 2020, the number of incidence of major KRAS G12C-mutated cancers in China increased from 38,000 to 43,000, and is expected to reach 58,000 ...
Recently, Hengrui and its subsidiaries SUZHOU SUNCADIA BIOPHARMACEUTICALS and Chengdu Suncadia Medicine received the “Drug Clinical Trial Approval Notice” approved and issued by the National Medical Products Administration to conduction a Ib/Phase II clinical study for HRS-1167 tablet (Merck code: M9466) combined with SHR-A1921 for injection or combined with bevacizumab or combined with abiraterone acetate tablets (I) and prednisone/prednisolone (AA-P) for the treatment of with advanced solid tumors. In October 2023, Hengrui and Merck reached a strategic cooperation. Merck obtained the exclusive rights to develop, produce and commercialize HRS-1167 (M9466) outside mainland China. This is also the first time for Hengrui to reach a strategic cooperation with large multinational companies. Poly(ADP-ribose) polymerase (PARP) is a multifunctional protein post-translational modification enzyme widely found in eukaryotic cells. It plays a role in maintaining gene stability and maintaining telomere length. Studies have found that PARP inhibitors can hinder DNA damage repair by selectively ...
Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) today announces the poster presentation of Phase II study final results of ASC40, a first-in-class fatty acid synthase (FASN) inhibitor for treatment of acne, at the 2024 American Academy of Dermatology (AAD) Annual Meeting in San Diego, the United States. The summary of the poster is shown as below: Title: First FASN inhibitor ASC40 to treat acne vulgaris patients: final results from a Phase 2 trial Method: This phase 2 trial (NCT05104125) was a randomized, double-blind, placebo-controlled, multicenter study. 180 patients were 1:1:1:1 assigned to the ASC40 25\50\75 mg or placebo QD for 12-week treatment and 2-week follow-up. Efficacy and safety of ASC40 vs placebo were assessed. Background: ASC40 (denifanstat) is a potent and selective small molecule inhibitor of fatty acid synthase (FASN). Mechanisms of action of ASC40 for acne treatment are novel: (1) direct inhibition of facial sebum production through inhibition of de ...
Recently, Hengrui Pharmaceuticals’ subsidiaries, Shanghai Shengdi Pharmaceuticals Co., Ltd. and Suzhou Shengdia Biopharmaceuticals Co., Ltd. received the Notice of Approval for Drug Clinical Trial approved by the State Drug Administration, which authorizes the company to carry out the clinical trial of adelberizumab in combination with SHR-A1811 for the treatment of breast cancer. According to the data released by the International Agency for Research on Cancer (IARC) of the World Health Organization in 2020, breast cancer has become the world’s number one malignant tumor and is the most common malignant tumor in women. Statistics show that in 2020, there were about 2.26 million newly diagnosed cases of female breast cancer and 685,000 deaths worldwide, ranking first in female malignant tumor morbidity and mortality. The incidence and mortality rates of breast cancer worldwide vary according to regional distribution. In China, the 2020 China Cancer data show that the incidence rate of breast ...
NANJING, China and GAITHURSBURG, Md., Feb. 26, 2024 /PRNewswire/ — TransThera, a clinical-stage biopharmaceutical company dedicated to innovating differentiated drugs globally, today announced the initiation of IND-enabling studies for TT-02332, a potent, selective and highly CNS-penetrating NLRP3 inflammasome inhibitor. The NLRP3 inflammasome is a pivotal component of the human innate immune system. Aberrant activation of NLRP3 is strongly linked with a variety of inflammatory disorders, including obesity, neurodegenerative diseases, NASH, inflammatory bowel disease (IBD), dermatitis, and atherosclerosis. “Immuno-inflammation is one of TransThera’s key therapeutic areas of interest. Over the past three years, we have achieved breakthroughs with the NLRP3 inhibitor program.” said Jennifer Sheng, Vice President of Biology at TransThera. “Our clinical candidate compound TT-02332 is a highly potent NLRP3 inhibitor that has shown promising efficacy in a number of disease-relevant in vivo animal models. The compound exhibits desirable pharmacokinetic/ pharmacodynamic (PK/PD) properties, suitable for once-daily dosing. TT-02332 demonstrates an ...
On February 23, 2024, Abbisko Therapeutics announced that its independently developed new-generation EGFR Exon20ins inhibitor ABSK112 has completed the first patient administration in its Phase I clinical trial for non-small cell lung cancer (NSCLC). Previously, ABSK112 has obtained clinical research licenses from China’s National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA), and is conducting Phase I clinical trials simultaneously in China and the United States. ABSK112 is a new generation of EGFR Exon20ins oral inhibitor with high activity, high selectivity and brain entry properties. Compared with the previous generation of EGFR Exon20ins inhibitors that have been on the market or entered clinical trials, ABSK112 has demonstrated better brain entry properties, high selectivity against wild-type EGFR, and broader Exon20ins mutation coverage in preclinical studies. It has shown excellent in vivo efficacy in multiple mouse tumor models with EGFR Exon20ins mutations. It has the potential to obtain ...
Dong Bao Zi Xing Ltd., a wholly-owned subsidiary of Tonghua Dongbao Pharmaceutical Co., Ltd. (the “Company”), has recently completed a pivotal Phase I clinical trial of a dual-target XO/URAT1 inhibitor for gout (THDBH151 tablets) and obtained a clinical trial summary report, which shows that the study results have reached the primary endpoint. The results of the study showed that the primary endpoints were met. The results of the “Phase I Clinical Study of the Safety, Tolerability, Pharmacogenetics/Pharmacodynamics and Effect of Food of THDBH151 Tablets in Healthy Adult Subjects with Single and Multiple Doses” conducted by the Company showed that the product was safe and well-tolerated in healthy Chinese adult subjects, with overall adverse event rates similar to or slightly lower than those of placebo, and that all adverse events were similar to or lower than those of placebo. The overall adverse event rate was similar to or slightly lower than ...
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