CStone Pharmaceuticals announced that the clinical trial application of lolatinib for ROS1-positive advanced non-small cell lung cancer in China has been accepted by the China National Medical Products Administration

Suzhou, China, October 20, 2021/PRNewswire/ - CStone Pharmaceuticals (Hong Kong Stock Exchange code: 2616), a leading biopharmaceutical company focusing on research, development and commercialization of innovative tumor immunotherapies and precision therapeutic drugs, It was announced today that the clinical trial application (IND) of lorlatinib (lorlatinib, formerly known as loratinib) for ROS1-positive advanced non-small cell lung cancer (NSCLC) has been accepted by the National Medical Products Administration (NMPA) of China
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This study aims to evaluate the anti-tumor activity and safety of lolatinib in patients with ROS1-positive advanced NSCLC, and is also the world’s first pivotal study of lolatinib in the treatment of ROS1-positive NSCLC

Lolatinib is a third-generation ALK/ROS1 tyrosine kinase inhibitor (TKI) with central nervous system penetration
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With its stunning data in the CROWN study [1], loratinib has been approved by the U.

In June 2021, CStone Pharmaceuticals announced that it will cooperate with Pfizer in the Greater China region for ROS1-positive NSCLC to jointly develop loratinib.
This is the further deepening of the cooperation between CStone Pharmaceuticals and Pfizer last year after they reached a strategic cooperation
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Dr.
Yang Jianxin, Chief Medical Officer of CStone Pharmaceuticals, said: “At present, ROS1-positive NSCLC patients have developed resistance to crizotinib and lack effective treatment methods
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We are very pleased to see that loratinib has obtained IND in China.

In clinical studies, loratinib also showed excellent efficacy and good safety for ROS1-positive advanced NSCLC
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In a phase I/II study, loratinib improved the objective response rate (ORR) and intracranial ORR in patients with ROS1-positive advanced NSCLC who were newly treated or failed crizotinib treatment

In September 2020, CStone Pharmaceuticals and Pfizer reached a strategic cooperation, including Pfizer’s US$200 million equity investment in CStone Pharmaceuticals, CStone’s authorization of Pfizer to develop and commercialize suggliumab in mainland China, and CStone Pharmaceuticals and Pfizer will introduce more oncology products into the framework of cooperation in the Greater China region
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CStone Pharmaceuticals and Pfizer will jointly select oncology products in the Pfizer pipeline that are in the late stage of research and development (that have passed the proof-of-concept) and jointly develop them in the Greater China region.

[1] The CROWN study is a head-to-head study comparing the efficacy and safety of loratinib and crizotinib in the first-line treatment of untreated ALK-positive NSCLC

About Lorlatinib

Lolatinib is an oral macrocyclic adenosine triphosphate competitive small molecule inhibitor of ROS1 and ALK receptor tyrosine kinase
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In preclinical studies, for ROS1 or ALK rearrangement, in crizotinib-resistant ROS1 mutations and crizotinib, aletinib, ceritinib, and Brigatinib-resistant ALK-acquired mutations, Luo Latinib shows potent and selective inhibitory activity, and can penetrate the blood-brain barrier

About CStone Pharmaceuticals

CStone Pharmaceuticals (Hong Kong Stock Exchange Code: 2616) is a biopharmaceutical company that focuses on research, development and commercialization of innovative tumor immunotherapy and precision treatment drugs to meet the ardent medical needs of cancer patients in China and around the world
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Established at the end of 2015, CStone Pharmaceuticals has assembled a world-class management team with extensive experience in new drug development, clinical research and commercial operations

For more information, please visit
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Forward-looking statement

The forward-looking statements made in this article only relate to events or information as of the date when the statement is made in this article
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Except as required by law, we have no obligation to update or publicly revise any forward-looking statements and unexpected events after the date of forward-looking statements, regardless of whether new information, future events or other circumstances appear

Source: CStone Pharmaceuticals