![]() If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act Any of these intentions may alter in light of future development.īlueprint Medicines, GAVRETO and associated logos are trademarks of Blueprint Medicines Corporation.Approximate date of commencement of proposed sale to public:Īs soon as practicable after this Registration Statement is declared effective. 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. 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. 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. ![]() 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. With an experienced team, a rich pipeline, a robust clinical development-driven business model and substantial funding, CStone’s vision is to become a world-renowned biopharmaceutical company that is leading the way to conquering cancer.įor more information about CStone, please visit: Forward-looking Statement With a strategic emphasis on immuno-oncology combination therapies, the Company has built an oncology-focused pipeline of 16 drug candidates, including 5 late-stage candidates at pivotal trials or registration stages. Established at the end of 2015, CStone has assembled a world-class management team with extensive experience in innovative drug development, clinical research, and commercialization. We hope to deliver pralsetinib to a wide range of patients with RET-altered cancers in China.”ĬStone has an exclusive collaboration and license agreement with Blueprint Medicines for the development and commercialization of pralsetinib in Greater China, which encompasses Mainland China, Hong Kong, Macau and Taiwan.ĬStone is a biopharmaceutical company focused on developing and commercializing innovative immuno-oncology and precision medicines to address the unmet medical needs of cancer patients in China and worldwide. Frank Jiang, Chairman and CEO of CStone, “ In China, the National Medical Products Administration has accepted pralsetinib’s new drug application with priority review designation for the treatment of patients with RET fusion-positive non-small cell lung cancer. FDA for the treatment of patients with RET-altered thyroid cancers,” said Dr. “We are pleased that pralsetinib has been approved by the U.S. by Blueprint Medicines and Genentech, a wholly owned member of the Roche Group, under Blueprint Medicines’ collaboration with Roche.ĭeveloped by CStone’s partner Blueprint Medicines, pralsetinib is a once-daily oral treatment designed to potently and selectively target RET alterations that drive multiple tumor types. The therapy is jointly commercialized in the U.S. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.Įarlier this year, the FDA granted accelerated approval to GAVRETO for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer as detected by an FDA approved test. The accelerated approval expands the labeled indications for GAVRETO to include adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy, or with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). Food and Drug Administration (FDA) has approved GAVRETO™ (pralsetinib) for the treatment of patients with RET-altered thyroid cancers. SUZHOU, China, December 10th, 2020 – The partner of CStone Pharmaceuticals (“CStone”, HKEX: 2616), Blueprint Medicines, announced on December 1st that the U.S. Expands GAVRETO label following initial approval for RET fusion-positive non-small cell lung cancer in September 2020.
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