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  • 1Regor announces China NMPA approval of the IND for RGT-419B capsule, a CDK2/4/6 inhibitor for advanced/metastatic breast cancer

    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 rCARDTM (Computer Accelerated Rational Discovery) Platform. The company focuses mainly on three therapeutic areas, oncology, immunology, and metabolic disorders. By seamlessly integrating rCARDTM 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.

    Media Contact:

      Lauren Xuan

      Email: lili.xuan@qlregor.com



  • 2Regor announces the first patient dosed in the U.S. in the Phase II clinical trial for RGT-075, a novel small molecule GLP-1R agonist

    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 rCARDTM (Computer Accelerated Rational Discovery) Platform. The company focuses mainly on three therapeutic areas, oncology, immunology, and metabolic disorders. By seamlessly integrating rCARDTM 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.

    Media Contact:

      Lauren Xuan

      Email: lili.xuan@qlregor.com



  • 3Regor announces the first patient dosed in the U.S. in the Phase I clinical trial for RGT-419B, a CDK2/4/6 inhibitor for advanced/metastatic breast cancer

    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 Group is a clinical stage company dedicated to the discovery and development of innovative and clinically differentiated medicines by leveraging the proprietary rCARDTM (Computer Accelerated Rational Discovery) Platform. The company focuses mainly on three therapeutic areas, oncology, immunology, and metabolic disorders. By seamlessly integrating rCARDTM 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.

    Media Contact:

      Lauren Xuan

      Email: lili.xuan@qlregor.com



  • 4Building a New Generation AI Engine and Jointly Accelerating World-Class Innovative Drug Discovery and Development
    -- NVIDIA and Regor Therapeutics Group Enter into Collaboration

    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 - rCARDTM - 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 rCARDTM platform, including NVIDIA Clara Discovery and the AutoDock-GPU suite. By leveraging GPU-powered parallel processing capabilities across multiple computing nodes, the rCARDTM 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 rCARDTM 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 rCARDTM 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 rCARDTM 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 rCARDTM 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 rCARDTM 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 rCARDTM (Computer Accelerated Rational Discovery) Platform. The company focuses mainly on three therapeutic areas, oncology, immunology, and metabolic disorders. By seamlessly integrating rCARDTM 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.

    Media Contact:

      Lauren Xuan

      Email: lili.xuan@qlregor.com



  • 5Regor and Lilly Enter into Strategic Collaboration to Discover and Develop Novel Therapies for Metabolic Disorders

    INDIANAPOLIS and SHANGHAI, Dec. 10, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Regor Therapeutics Group have entered into a multi-year research collaboration and licensing agreement to discover, develop and commercialize novel therapies for metabolic disorders.

    Under the terms of the agreement, Lilly will have a license to select Regor intellectual property with an option to extend the license. Lilly will be responsible for clinical development, manufacturing and commercialization worldwide, except for People's Republic of China, Macau, Hong Kong and Taiwan, where Regor will maintain these rights and responsibilities. The agreement will allow each company the opportunity to fully leverage both parties' existing compounds and technologies globally to maximize patient treatment choice.

    "Through this collaboration, we will have the opportunity to expand treatment options available to patients suffering from metabolic disorders," said Ruth Gimeno, Ph.D., vice president, diabetes research and clinical investigation at Lilly. "Regor's technology will also allow Lilly to further accelerate innovation and deliver breakthrough therapies in obesity and diabetes."

    "In a little over three years, Regor has established a world-class research organization exemplified by our Computer Accelerated Rational Discovery platform. This collaboration is a recognition for Regor's core technology and research capabilities, but more importantly, it is an extraordinary opportunity to discover, develop and commercialize novel therapeutics to help the millions of patients in the world, "said Xiayang Qiu, Ph.D., founder CEO of Regor. "We are pleased to establish this strategic collaboration with Lilly, a top global leader in metabolic disorders such as diabetes and obesity."

    Regor will receive an upfront payment of up to $50 million, which partially includes an equity investment by Lilly in Regor, subject to the parties entering into standard equity agreements. The company is also eligible to receive up to $1.5 billion in potential payments based on the achievement of prespecified preclinical, clinical development and commercial milestones, as well as tiered royalties from low-single to low-double digits on sales resulting from the agreement.

    This transaction will be reflected in Lilly's reported results and financial guidance according to Generally Accepted Accounting Principles (GAAP). There will be no change to Lilly's 2021 non-GAAP earnings per share guidance as a result of this transaction.

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

    About Eli Lilly and Company

    Lilly is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com. C-LLY

    Lilly Forward-Looking Statement

    This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about the benefits of a collaboration between Lilly and Regor Therapeutics, Lilly's research and development strategy, and potential payments to Regor in connection with the collaboration and reflects Lilly's current beliefs and expectations. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug research, development and commercialization. Among other things, there can be no guarantee that Lilly will realize the expected benefits of the collaboration, that the collaboration will yield commercially successful products or that Lilly will execute their strategy as expected. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

    Refor to

      Jordan Bishop; jordan.bishop@lilly.com; 317-473-5712 (Media)

      Kevin Hern; hern_kevin_r@lilly.com; 317-277-1838 (Investors)

      Lauren Xuan; communications@qlregor.com; +86-21-31168236 (Regor Media)

      Min Zhong; min.zhong@qlregor.com; +86-21-31168226 (Regor Investors)

    www.regor.com



    PR Newswire Link



  • 6Regor Therapeutics Announces Completion of $90 Million Series B Financing

    SHANGHAI, Feb. 18, 2021 /PRNewswire/ -- Regor Therapeutics, a clinical stage biotechnology company dedicated to the discovery of innovative medicines to treat cancer, immune disorders and metabolic diseases, announces the successful completion of $90 million Series B financing.

    Founded in July of 2018 by a group of veteran drug hunters with extensive research and executive leadership experiences at top multinational pharmaceutical companies, Regor aims to establish world-class innovation capabilities and is committed to delivering clinically differentiated, best- and first-in-class drugs to serve patients globally.  By leveraging CARD, Computer Accelerated Rational Discovery, a proprietary enabling technology platform, the team has successfully advanced numerous discovery programs in a dramatically accelerated fashion, including from ideas to a clinical start in two years.  

    The Series B financing was led by Lilly Asia Ventures and included participation from Loyal Valley Capital, Lanting Capital, TF Capital and Vertex Ventures China. Regor Therapeutics was established with initial series A strategic investment from Qilu Pharmaceutical Group, a well-known Chinese pharmaceutical company.

    "We are very pleased with the strong support from leading life science investment firms in this financing round. We are now in a strong position to advance pre-clinical and clinical studies of multiple programs," said Dr. Xiayang Qiu, Founder and CEO of Regor. "We are looking forward to long-term collaborations with our investors, as we aim to improve the treatment outcomes for worldwide patients of chronic diseases, cancer and other life-threatening diseases."

    "We are proud to support Regor Therapeutics' world-class team to expand its efforts across a larger number of programs and therapeutic areas to develop tomorrow's life-saving treatments," said Dr. Yi Shi, managing partner of Lilly Asia Ventures.

    "With the next decade comes a historical moment for China's leap upwards. We are delighted to collaborate with veteran scientists, leading entrepreneurs and investment partners in biopharma industry. Together we are working hard for a better world by innovative and transformative medicines which make meaningful impacts to patients globally," said Mr. Andy Lin, founding partner of Loyal Valley Capital.

    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, seamlessly integrating structural biology, computational chemistry, therapeutic biology, medicinal chemistry, and clinical development. Regor has assembled a world-class scientific team and demonstrated high efficiency in producing best- and first-in-class molecules.

    About Lilly Asia Ventures

    Lilly Asia Ventures (LAV) is a leading biomedical venture capital firm founded in 2008, with offices in Shanghai, Hong Kong, and Palo Alto. Our vision is to become the trusted partner for exceptional entrepreneurs seeking smart capital and to build great companies developing breakthrough products that treat diseases and improve human health.

    About Loyal Valley Capital

    Loyal Valley Capital ("LVC"), founded in 2015, is a thematic, research-oriented private equity firm that has been a "partner of choice" for China's most promising companies. LVC has left a mark in leading players such as Tik Tok, Didi, Bilibili, Junshi, InnoCare, Akeso, Pop Mart, SUPCON. In 2020, LVC was honorably awarded the "Top 10 Most Influential Private Equity Firms in China", "Top 20 Healthcare Investor in China", "Top 10 Innovative Drug Investor in China", and "Top 20 Consumer Investor in China".

    About Lanting Capital

    LanTing Capital (LTC) is a cross-border, pharmaceutical-focused strategic private equity firm. Founded by pharmaceutical veterans and asset management experts, LTC leverages our unparalleled industry knowledge and network plus deep financial market know-how across the USA, China and Europe to unlock unique cross-border growth opportunities for our portfolio companies and investors. LanTing is currently operating in Princeton (USA), Milan (Italy), Saanen (Switzerland), and Hangzhou (China).

    About TF Capital

    TF Capital focuses on investment in the life sciences industry, primarily investing in early-stage companies with high potential.  Through strategic investments in various key areas and right partnerships, TF Capital hopes to capture opportunities in the rapidly expanding Chinese life sciences market. Our investment team has vast experience and resources in industry to assist our portfolio companies.

    About Vertex Ventures China

    Vertex Ventures is a global network of venture capital funds, who is a member of Tamasek Holdings. The operator-investors manage portfolios in China, the U.S., Israel, India and Southeast Asia. Vertex Ventures China, founded in 2008, has offices in Beijing, Shanghai and Shenzhen. It is currently managing both Dollar and RMB funds, with assets under management of over ¥10 billion. Vertex Ventures China invests in high-growth innovative start-ups across mainland China, covering the fields of deep tech, new digital economy and healthcare. Some of its notable investments include 91 Wireless, Chipscreen, mobike, Horizon Robotics, Harbour Biomed, Changba, Edge Medical, Inmagene, Infinovo, etc. 

    www.regor.com



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