Shanghai, Nov. 3, 2022 – Regor Therapeutics, a clinical-stage biotech company, announced today the Investigational New Drug (IND) Application for RGT-264 phosphate tablet, a small molecular selective hematopoietic progenitor kinase (HPK1) inhibitor has been approved by the National Medical Products Administration (NMPA) of China.

RGT-264 phosphate tablet is a highly potent and selective HPK1 inhibitor. HPK1 kinase activity suppresses the immune functions of a wide range of cells including T cells and dendritic cells (DCs) 1. Therefore, inhibiting HPK1 activity serves as a promising approach for cancer immunotherapy. Currently, there is no HPK1 inhibitor approved globally.

The phase 1 clinical trial is the first-in-human (FIH) study of RGT-264 phosphate tablet, aims to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary anti-tumor activity of RGT-264 as the monotherapy in subjects with advanced solid tumors.

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 rCARD^TM platform. The company focuses mainly on three therapeutic areas, oncology, immunology, and metabolic disorders. By seamlessly integrating rCARD^TM with structural biology, computational chemistry, 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.

Reference

1. Wang X, Li JP, Chiu LL, et al. Attenuation of T cell receptor signaling by serine phosphorylation-mediated lysine 30 ubiquitination of SLP-76 protein. J Biol Chem. 2012;287(41):34091-34100. doi:10.1074/jbc.M112.371062

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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.

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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.

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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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Shanghai, March 24, 2022: Regor Therapeutics Group and NVIDIA Corporation today entered into collaboration that makes Regor Therapeutics Group a unique biotech company in China to have in-depth access to NVIDIA Inception. Regor Therapeutics Group will work closely with NVIDIA to integrate high performance computing technology into Regor's proprietary Artificial Intelligence innovation platform - rCARD^TM - to accelerate the discovery and development of innovative drugs.

The NVIDIA Inception is a program designed to nurture pioneering biotech startups. In this collaboration, NVIDIA will contribute its industry-leading GPU products and high performance computing to the rCARD^TM platform, including NVIDIA Clara Discovery and the AutoDock-GPU suite. By leveraging GPU-powered parallel processing capabilities across multiple computing nodes, the rCARD^TM platform will aim to accelerate the drug discovery process, reduce R&D costs, and improve success rate of drug development. This collaboration marks another milestone in Regor's mission to accelerate innovation and bring breakthrough innovative drugs to patients worldwide.

The rCARD^TM platform is a proprietary and highly efficient drug discovery and development platform. With foundations of scientific expertise in structural biology, computational biology and computational chemistry, the rCARD^TM platform fully integrates advanced artificial intelligence algorithms with the extensive knowledge and experiences of our seasoned drug hunters in drug research and discovery. Regor is aiming to expand the capabilities of the rCARD^TM platform and build a new generation of world-class innovative drug discovery engine through this collaboration.

"We are very excited about AI in drug discovery and its potential disruptive impacts in our industry," said Dr. Wenge Zhong, Chief Technology Officer of Regor Therapeutics Group, "Since the inception, Regor has built an interdisciplinary team of scientists and embarked on establishing the rCARD^TM platform to integrate artificial intelligence with our collective knowledge and experience in drug discovery. We are pleased to enter into this holistic collaboration with industry leader NVIDIA in AI and high performance computing to further expand and strengthen our rCARD^TM platform capabilities. We hope that together NVIDIA and Regor can help to demonstrate the power of AI in the discovery and development of innovative drugs that will benefit patients around the world."

Renee Yao, director of global healthcare startups at NVIDIA, said: "We are excited to partner with Regor Therapeutics Group to unveil a new chapter in the integration of artificial intelligence into the biopharmaceutical industry. Through this partnership, we will enable Regor to systematically enhance its HPC and AI capabilities on top of NVIDIA's software-defined computing platform, accelerating the convergence of multidisciplinary technologies such as big data, artificial intelligence, high performance computing and innovative drug development. "

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. To learn more about Regor, please visit us at www.regor.com.

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Shanghai, March 19, 2022: Today, Qilu Regor Therapeutics Inc. ("Regor") and two of its co-founders, Dr. Xiayang Qiu and Dr. Min Zhong, filed their responses in the Connecticut federal district court to a lawsuit filed by Pfizer Inc. ("Pfizer") in early February. In their court filing, Regor, Dr. Qiu, and Dr. Zhong not only rejected each of Pfizer's baseless allegations, but further raised multiple counterclaims, asking that the court issue a declaratory judgment that they never misappropriated any Pfizer trade secrets and that Regor is the rightful owner of the underlying patents.

The court filing explains in detail how Regor has independently discovered its drug candidates. Specifically, Regor's Chief Technology Officer, Dr. Wenge Zhong, who was the Senior Director and Head of Discovery Modalities at Amgen's Asia Research and Development Center before joining Regor, led a team of dedicated scientists and collaborated with a network of world-leading contract research organizations ("CROs") in China in expediting the discovery and development of the novel and inventive molecules in Regor's patent applications. The court filing demonstrates that, contrary to Pfizer's claims, Regor's patents were not built on trade secret misappropriation, but on the basis of literature and patents in the public domain and Regor team's ingenuity and hard work. Moreover, armed with Regor's proprietary Computer Accelerated Rational Discovery ("CARD") platform, which is now used consistently to facilitate target prioritization, decision making, and acceleration of the entire discovery process, Regor has made impressive achievements well beyond the GLP-1 related patents mentioned in this lawsuit: Regor has filed over 30 patents for ten drug discovery programs across three therapeutic areas in less than 4 years.

The court filing also explains Dr. Xiayang Qiu and Dr. Min Zhong's true reason for departing from Pfizer and co-founding Regor and further refutes Pfizer's meritless allegation of trade secret misappropriation. The court filing further points out that, while Pfizer had access to much of the information on which its lawsuit is based when Dr. Min Zhong and Dr. Xiayang Qiu left Pfizer in mid-2018, Pfizer did not express any concerns over their departures until over three and half years later, after Regor began to show promising signs of success.

"We never misappropriated Pfizer's trade secrets and we are confident that, once the truth comes to light, we will prevail in this litigation." said Dr. Min Zhong, co-founder and COO of Regor.

"We will vigorously defend against this meritless lawsuit," Xiayang Qiu, Regor's co-founder and CEO, commented, "but Regor will not be distracted by this lawsuit and remains committed to delivering clinically differentiated, best- and first-in-class drugs to serve patients globally."

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. For more information, please click www.regor.com

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