CStone Pharmaceuticals Announces Acceptance of New Drug Applications for Pratinib in Taiwan, China

Dr.

The acceptance of the new drug application of pratinib in Taiwan, China is based on a global phase I/II ARROW clinical study, which aims to evaluate the efficacy of pratinib in RET fusion-positive non-small cell lung cancer, RET mutant Safety, tolerability, and efficacy in patients with medullary thyroid carcinoma and other RET-fused advanced solid tumors

Results of the ARROW study in patients with RET fusion-positive NSCLC worldwide were presented at the June 2021 American Society of Clinical Oncology (ASCO) annual meeting

Results of the ARROW trial in patients with RET-mutant thyroid cancer worldwide were published in The Lancet Diabetes & Endocrinology in August 2021

About RET fusion-positive non-small cell lung cancer 

In recent years, the incidence of lung cancer has continued to increase in China

In the field of lung cancer, driver gene mutations such as EGFR, ALK, and ROS1 have been widely popularized, and targeted drugs for these driver genes have been approved for marketing

About RET mutant thyroid cancer

Thyroid cancer is the most common endocrine malignancy , and its incidence has increased significantly in recent years

Thyroid cancer is clinically divided into several subtypes such as papillary carcinoma, follicular carcinoma, anaplastic carcinoma and medullary carcinoma.

RET fusions and activating mutations are key disease drivers in many cancer types, including NSCLC and many types of thyroid cancer

About Pratinib

Pratinib, an oral, once-daily, potent and highly selective RET inhibitor, has been approved by the China National Medical Products Administration for the treatment of transfection-rearranged (RET) genes who have received prior platinum-containing chemotherapy Adult patients with fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)

Pratinib for advanced or metastatic RET-mutant medullary thyroid cancer (MTC) requiring systemic therapy and advanced or metastatic RET fusion-positive thyroid cancer requiring systemic therapy that is refractory to radioactive iodine (if radioactive iodine is appropriate) The application for new indications of the drug has also been accepted by the China National Medical Products Administration (NMPA) in April 2021 and has been included in priority review

The U.

The European Commission (EC) has granted conditional marketing authorization to GAVRETO as a monotherapy for the treatment of adult patients with RET fusion-positive advanced NSCLC who have not received prior RET inhibitor therapy

Pratinib is not approved for other indications in China, the United States, or Europe

Pratinib is designed to selectively and efficiently target oncogenic RET mutations, including secondary RET mutations that may lead to treatment resistance

Pratinib is a potent and selective RET inhibitor developed by CStone partner Blueprint Medicines
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CStone has entered into an exclusive collaboration and license agreement with Blueprint Medicines to obtain exclusive development and commercialization rights for Pratinib in Greater China
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Blueprint Medicines and Roche are jointly developing GAVRETO globally (excluding Greater China) for the treatment of patients with RET-mutant NSCLC, thyroid cancer and other solid tumors
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Blueprint Medicines and Genentech, a member of the Roche Group, are co-commercializing GAVRETO in the United States, and Roche has exclusive commercialization rights for GAVRETO outside the United States (excluding Greater China)
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The FDA granted GAVRETO Breakthrough Therapy Designation for the treatment of RET fusion-positive NSCLC that has progressed after platinum-based chemotherapy, and RET-mutation-positive medullary thyroid cancer that requires systemic therapy and for which no alternative therapy is available
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About CStone

CStone Pharmaceuticals (SEHK: 2616) is a biopharmaceutical company focused on the research, development and commercialization of innovative immuno-oncology and precision medicines to meet the high medical needs of cancer patients in China and around the world
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Founded in late 2015, CStone has assembled a world-class management team with extensive experience in new drug R&D, clinical research and commercial operations
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With tumor immunotherapy combination therapy as the core, the company has established a rich product pipeline consisting of 15 tumor candidates
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To date, CStone has received approvals for six new drug marketing applications
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Several late-stage drug candidates are in pivotal clinical trials or registration stages
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CStone's vision is to become a world-renowned biopharmaceutical company leading the way in the fight against cancer
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For more information, please visit .

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Except as required by law, we undertake no obligation to update or publicly revise any forward-looking statements and unanticipated events after the date on which they are made, whether as a result of new information, future events or otherwise
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Please read this article carefully and understand that our actual future results or performance may differ materially from expectations
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All statements in this article are made as of the date of this article and are subject to change due to future developments
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  https://gco.
iarc.
fr/today/data/factsheets/populations/160-china-fact-sheets.
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