Suzhou, China (Press Release) – 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 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.

For more in­for­ma­tion about CStone Pharma­ceu­ticals, please visit: www.cstonepharma.com.

Source: CStone Pharma­ceu­ticals.