On May 9, 2018, Anlotinib Hydrochloride Capsules (trade name: Focovite®), a
Class 1.1 novel drug independently developed by Zhengda Tianqing Pharmaceutical
Group, obtained the marketing approval certificate issued by the National
Medical Products Administration (NMPA). This marks the official launch of
anlotinib, a highly anticipated domestically innovative drug in China's oncology
field. Wang Shanchun, President of Zhengda Tianqing Pharmaceutical Group,
stated, "We expect this domestically developed new drug to benefit more Chinese
patients and even those worldwide after its launch."
After over a decade of dedicated research and development efforts, the R&D team of Zhengda Tianqing finally achieved a breakthrough in oncology drug development with the approval of Anlotinib Hydrochloride Capsules, a Class 1.1 novel drug. As a novel small-molecule multi-targeted tyrosine kinase inhibitor (TKI), this product effectively inhibits kinases including VEGFR, PDGFR, FGFR, and c-Kit, exerting dual mechanisms of action: anti-angiogenesis and tumor growth inhibition. Clinical trials have confirmed that Focovite® is currently the only oral monotherapy-effective anti-angiogenic targeted agent for advanced non-small cell lung cancer (NSCLC), characterized by mild adverse reactions and favorable patient tolerability. Industry experts analyze that anlotinib is expected to become the standard third-line treatment option for patients with advanced NSCLC.
"The approval and launch of anlotinib also benefit from the ongoing drug evaluation and approval reform initiatives of the NMPA. Given that clinical studies demonstrated significant clinical advantages of anlotinib over existing treatment modalities, the drug was included in the priority review pathway by the Center for Drug Evaluation (CDE) immediately upon its application submission. Thanks to the high priority attached by drug regulatory authorities and the overtime efforts of review experts, anlotinib completed the marketing review and approval process in a remarkably short period, enabling patients to access this safe and effective innovative anti-tumor drug as soon as possible," Wang Shanchun noted. He emphasized that during the review period of this drug, China was in the phase of drug evaluation and approval policy reform, with an increasingly clear policy orientation to encourage R&D and innovation. The approval of clinically valuable innovative drugs like anlotinib has thus been guaranteed and incentivized. Through the priority review procedure, the CDE has provided effective support for meeting clinical medication needs, reducing drug costs, and promoting public health.
Clinical research results indicate that Focovite® exhibits promising therapeutic efficacy not only in NSCLC but also in multiple cancer types including soft tissue sarcoma (STS) and ovarian cancer. Zhengda Tianqing is actively conducting multicenter clinical trials in regions including the United States. The phase 2b clinical study results of anlotinib for soft tissue sarcoma were presented as an oral talk at this year's American Society of Clinical Oncology (ASCO) Annual Meeting, while the pathological subgroup results of its phase 3 clinical study for NSCLC were featured as a poster presentation at the same event and incorporated into the 2018 edition of the CSCO Guidelines for Lung Cancer. Wang Shanchun commented, "It is indeed remarkable for a domestically developed innovative drug in China to achieve such accolades prior to its marketing approval, which reflects international recognition of China's innovative pharmaceuticals."
