Sihuan Pharmaceutical Holdings Group Co., Ltd. (HKEx stock code 00460), a cardio-cerebral vascular drug manufacturer in the Chinese prescription drug market, announces that, Pirotinib, an innovative anti-tumor drug independently developed by it, has completed Phase I clinical trial in the United States and officially started Phase II clinical trial in China
~~~~~~ ~~~~~~Sihuan Pharmaceutical Holdings Group Co., Ltd. (HKEx stock code 00460), a cardio-cerebral vascular drug manufacturer in the Chinese prescription drug market, announces that, Pirotinib, an innovative anti-tumor drug independently developed by it, has completed Phase I clinical trial in the United States and officially started Phase II clinical trial in China, which is led by Professor Wu Yilong, a lung cancer expert. Pirotinib is a blockbuster drug under Sihuan’s layout related to anti-tumor drugs, and this clinical trial is an important milestone in its development of innovative drugs. Pirotinib is a new generation of multi-target, irreversible tyrosine kinase inhibitor against epithelial growth factor receptor (EGFR) family and others, and is intended to treat a variety of malignant tumors such as non-small cell lung cancer, with considerable market prospect.
The trial was led by Professor Wu Yilong, a lung cancer expert, the chairman of the Professional Committee for Lung Cancer of China and the executive director of the Chinese Society of Clinical Oncology (CSCO). Recently, the first subjects have been successfully enrolled. Previously, Phase I clinical trial on Pirotinib has been completed at three well-known cancer research centers in the United States. The phased results were published last year at the annual conference of the American Society of Clinical Oncology (ASCO), which is the world's largest oncology organization.
Subjects have shown good pharmacokinetic characteristics and pharmacodynamic responses with excellent safety and tolerable adverse reactions. Previous in vitro and in vivo researches have shown that Pirotinib also has an inhibitory effect on non-small cell lung cancer caused by certain EGFR mutation sites, on which current targeted drug therapy has no efficacy. The obtaining of US FDA's clinical approval and the completion of US Phase I clinical trial will accelerate the clinical advancement of the new drug in China. It is expected to undergo Phase III clinical trial in the second half of 2019.
EGFR mutation leads to malignant tumors such as lung cancer, stomach cancer, and esophageal cancer. Currently, there are no effective treatments worldwide. Lung cancer is one of the malignant tumors with high mortality and incidence in China. According to GlobalData, the global market capacity for non-small cell lung cancer therapy reached US$20.93 billion in 2016, and would increase at a double-digit compound growth rate in the next few years. Pirotinib has the potential to effectively inhibit these carcinogenic mutations, and its market prospect is considerable.
Sihuan began a layout of innovative drug R&D as early as 2008, and has established a mature innovative drug R&D platform and gathered experts in various subareas of innovative drug R&D. Its team has extensive experience in working at international pharmaceutical company, and it ranks among the best in terms of the strength of independent R&D of new drugs. In 2017, the Group's R&D expenditures accounted for approximately 11% of its total operating revenue, above the industry average level.
Mr. Che Fengsheng, Executive Director and Chairman of Sihuan Pharmaceutical, said: Sihuan Pharmaceutical has continued to promote and invest in innovative drug R&D in the past 10 years; its innovative drug R&D platform has become relatively mature, and it has established a clear pipeline to focus on therapeutic areas with significant clinical needs, including cardio-cerebral vascular disease, tumor, diabetes, non-alcoholic hepatitis, and pain. The R&D results of Pirotinib are good proof of the R&D strength of Sihuan. Sihuan expects to apply for production of it as soon as 2021. After launch, it will provide better treatment options to clinicians and patients. Facing the future, Sihuan has developed a defined, clear and firm sales and marketing strategy. Sihuan has made a series of internal adjustments and is committed to “strengthening R&D capabilities, optimizing product resources and accelerating market expansion”, and is moving towards the next stage of development, contributing to the Group's sustainable development and creating better returns to shareholders.
The generic drugs team and platform of Sihuan Pharmaceutical has become very mature, and has successfully developed a number of first generic drugs which has been launched to the market. According to its annual report, Sihuan has selected several oral solid drugs for generic drugs consistency evaluation. One of them is Metformin Hydrochloride Tablet, a first-line drug for treating diabetes, which is expected to pass the consistency evaluation soon and will promote the profit growth of Sihuan after launch. The generic drug pipeline of Sihuan Pharmaceutical also includes cardio-cerebral vascular drugs such as Vinpocetine Injection, Rivastigmine Hydrogen Tartrate Capsule, Levetiracetam Tablet, Levamlodipine Besylate Tablet, and Levetiracetam Injection. The diversified variety and multiple layout ensure the short-, medium- and long-term product resources of the Group.
