On April 20, 2022, Regor Therapeutics Group announced that the investigational new drug (IND) application of RGT-419B capsule, a CDK2/4/6 small molecule inhibitor, had been approved by the National Medical Products Administration (NMPA) of China. A Phase I clinical study will be conducted in Chinese patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced/metastatic breast cancer, including patients who are resistant to approved CDK4/6 inhibitors, to evaluate the safety, tolerability and pharmacokinetic profile of RGT-419B capsule.

RGT-419B is the first of a series of innovative oncology drugs being developed by Regor Therapeutics Group. The U.S. Food and Drug Administration (FDA) approved its early clinical development plan for patients with HR+/HER2- advanced/metastatic breast cancer and the dosing of the first patient was accomplished on April 8, 2022.

About RGT-419B

RGT-419B is a new generation of CDK inhibitor with an optimized kinase activity spectrum. Results from non-clinical studies showed that RGT-419B demonstrated full suppression of ER+ breast cancer cell proliferation with acquired resistance to CDK4/6 inhibitors. Additionally, RGT-419B's tumor cell suppression was further augmented when combined with a selective estrogen receptor down-regulator or a PI3K signaling pathway inhibitor.

The clinical development program of RGT-419B is designed to address the unmet medical needs of patients who are refractory or have relapsed after previous treatment, providing new opportunities to improve survival and quality of life for patients with advanced/metastatic breast cancer.

About Breast Cancer

According to the latest cancer data released by the World Health Organization International Agency for Research on Cancer (IARC), breast cancer is the most commonly diagnosed cancer worldwide, with an estimated 2.26 million new cases in 2020. In China, breast cancer is the most common malignancy among women, with 416,371 new cases and 117,174 deaths in 2020. HR+/HER2- breast cancer is the most common subtype, accounting for over 70% of female patients. Breast cancer poses a tremendous medical burden and has a significant negative impact on patients and their families in China and across the world.

About Regor Therapeutics Group

Regor Therapeutics Group is a clinical stage company dedicated to the discovery and development of innovative and clinically differentiated medicines by leveraging the proprietary rCARD^TM (Computer Accelerated Rational Discovery) Platform. The company focuses mainly on three therapeutic areas, oncology, immunology, and metabolic disorders. By seamlessly integrating rCARD^TM with structural biology, computational biology, computational chemistry and other disciplines, Regor has successfully assembled a world-class scientific team and established a highly efficient new drug innovation engine to enable the discovery and development of best- and first-in-class molecules.

IR Contact:

  Investor Relations and Communications

  Email: ir@regor.com

Shanghai, April. 12, 2022 --Regor Therapeutics Group, a clinical-stage biotech company focusing on immunology, oncology, and metabolic disorders, announced today that the first patient has been dosed in the Phase II clinical trial of the Company’s novel oral small molecule GLP-1 receptor agonist RGT-075 in the U.S.

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are a well-characterized class of hypoglycemic agents used to treat patients with type 2 diabetes mellitus (T2DM). RGT-075 is a novel oral small molecule GLP-1 receptor agonist. The Phase II clinical trial is conducted in the form of randomized, multi-blind, multi-center placebo-controlled trial, exploring the efficacy and safety of RGT-075 in patients with type 2 diabetes mellitus who have poor glycemic control following metformin treatment. The first patient dosing of this trial has been completed in the U.S. The study was officially launched on March 30, 2022.

According to the International Diabetes Federation (IDF) Diabetes Survey 2021, there are an estimated 537 million adults with diabetes worldwide, and this number is expected to reach 643 million by 2030 and 784 million by 2045. Type 2 diabetes is the predominant type of diabetes and will continue to increase with rising rates of obesity and ageing.

About Regor Therapeutics Group

Regor Therapeutics Group is a clinical stage company dedicated to the discovery and development of innovative and clinically differentiated medicines by leveraging the proprietary rCARD^TM (Computer Accelerated Rational Discovery) Platform. The company focuses mainly on three therapeutic areas, oncology, immunology, and metabolic disorders. By seamlessly integrating rCARD^TM with structural biology, computational biology, computational chemistry and other disciplines, Regor has successfully assembled a world-class scientific team and established a highly efficient new drug innovation engine to enable the discovery and development of best- and first-in-class molecules.

IR Contact:

  Investor Relations and Communications

  Email: ir@regor.com

Shanghai, April. 8, 2022 --Regor Therapeutics Group, a clinical-stage biotech company focusing on immunology, oncology, and metabolic disorders, announced today that the first patient has been dosed in the Phase I clinical trial of the Company’s next generation targeted inhibitor RGT-419B for the treatment of breast cancer.

RGT-419B is a new generation CDK2/4/6, small molecule inhibitor with an optimized kinase activity spectrum. It is expected to combat the resistance to currently approved CDK4/6 inhibitors that are given in combination with endocrine-based therapy for treatment of pre/perimenopausal or postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer. The Phase I clinical trial is in the form of non-randomized, open-label first-in-human clinical study, exploring ascending dose of RGT-419B in hormone receptor-positive HER-2 receptor-negative patients with advanced or metastatic breast cancer under monotherapy or combination endocrine therapy conditions. The study was initiated in March 2022 and the first patient dosing was completed in the U.S.

Preclinical studies indicates that RGT-419B has demonstrated full suppression of cancer cell proliferation in a CDK4/6 inhibitor-resistant ER+ breast cancer cell model. Also, data from preclinical studies suggest that the inhibitory effect of RGT-419B on cancer cells is further enhanced when combined with selective estrogen receptor degraders (SERD) or PI3K inhibitors.

About Regor Therapeutics Group

Regor Therapeutics is a clinical stage company dedicated to the discovery and development of innovative and clinically differentiated medicines by leveraging the proprietary CARD (Computer Accelerated Rational Discovery) Platform. The company focuses mainly on three therapeutic areas, oncology, immunology, and metabolic disorders. By seamlessly integrating CARD with structural biology, computational chemistry, therapeutic biology, medicinal chemistry, and clinical development. Regor has successfully assembled a world-class scientific team and established a highly efficient new drug innovation engine to enable the discovery and development of best- and first-in-class molecules.

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IR Contact:

  Investor Relations and Communications

  Email: ir@regor.com