CStone received IND approval in China for HDAC6 inhibitor CS3003

CStone Pharmaceuticals (Suzhou) Co., Ltd. ("CStone", stock code: 2616.HK) announced that the National Medical Products Administration (NMPA) recently approved company's histone deacetylase 6 (HDAC6) selective inhibitor CS3003 for Phase I clinical trial in China. This is a multi-center, Phase I dose escalation study synchronously conducted in China and Australia in patients with advanced solid tumors and relapsed or refractory multiple myeloma.

Dr. Frank Jiang, Chairman and CEO, commented: "CS3003 is the ninth drug candidate of CStone with Investigational New Drug approval obtained in China. At present, there are no similar domestic and foreign products approved. We believe that CS3003 has the potential to become the first-in-class HDAC6-selective inhibitor in the world. We look forward to bringing a novel and effective treatment option to cancer patients."

"The selective inhibition of HDAC6 has the potential to produce better efficacy in multiple myeloma either as monotherapy or in combination with current standard of cares. Furthermore, preclinical data and early clinical studies of similar products in the same class have indicated that CS3003 has better safety profile than pan-HDAC inhibitors and the potential to develop combination therapies with immune checkpoint inhibitors for the treatment multiple types of solid tumors," said Dr. Jon Wang, Chief Scientific Officer of CStone.

About CS3003

CS3003 is a small molecule inhibitor that selectively targets histone deacetylase 6 (HDAC6). Unlike the other HDAC family members, HDAC6 is mainly located in the cytoplasm and has little effect on DNA histone acetylation. HDAC6 inhibition can enhance acetylation of cytoplasmic tubulin and lose the capability to clear unfolded or misfolded proteins, thereby promoting cell apoptosis. Selective inhibition of HDAC6 produces better efficacy in multiple myeloma and has improved safety profile over pan-HDAC inhibitors. CS3003 also has the potential to be combined with PD-(L)1 antibody drugs in solid tumors to expand the clinical efficacy of immunological checkpoint inhibitors.

About CStone

CStone Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative immuno-oncology and molecularly-targeted drugs to address unmet medical needs for cancer patients in China and worldwide. On February 26, 2019, CStone was listed on the Main Board of the Hong Kong, S.A.R., China Stock Exchange, stock code: 2616.

Since the Company's inception in 2015, CStone has assembled a world-class management team that has a full spectrum of complementary skillsets from preclinical research to clinical development and commercialization. Through dual sources of innovation, comprised of internal research and external partnership, the Company has built a rich oncology pipeline of 14 oncology drug candidates with significant mono- and combination-therapy potential and synergies, including 4 assets exclusively in-licensed in Greater China from Agios and Blueprint Medicines. Among CStone's portfolio, 4 late-stage drug candidates are at or near pivotal trials. CStone's business model has a clear focus on clinical development, while at the same time, the Company is rapidly developing its commercial and manufacturing capabilities. The Company is backed by prestigious VC and PE funds with record-breaking amounts of equity investment, raising a combined total of approximately USD 412 million in two financing rounds to date. With an experienced team, a rich pipeline, a robust clinical development-driven business model, and substantial funding, CStone's vision is to become globally recognized as a leading Chinese biopharmaceutical company by bringing innovative and differentiated oncology therapies to cancer patients worldwide.

Forward-looking Statement

The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article.  Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events.  You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect.  In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article.  Any of these intentions may alter in light of future development.

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