Led by Top Oncologist Professor Wu Yilong　Expected to Commence Phase III Clinical Trial in 2H2019

Demonstrates Strong R&D Capability   Solidifies Oncology Drug Development Strategy

 

HONG KONG, CHINA , - 13 August 2018 - Sihuan Pharmaceutical Holdings Group Ltd. (HKEx: 0460) ("Sihuan Pharmaceutical" or the "Group"), the largest cardio-cerebral vascular ("CCV") drug manufacturer in China's prescription drug market, announced that its self-developed oncology innovative drug commenced Phase II Clinical Trial in China (the "Study"), subsequent to the completion of Phase I Clinical Trial in the U.S.. Led by top oncologist Professor Wu Yilong, the progress of Pirotinib's Clinical Trial marks an important milestone in Sihuan Pharmaceutical's innovative drug research and development ("R&D"). 

 

A key product in the Group's oncology R&D pipeline, Pirotinib is a novel irreversible pan-epidermal growth factor receptor ("EGFR") tyrosine kinase inhibitor, intended for the treatment of various types of malignant tumor, including non-small cell lung cancer ("NSCLC"). The product is expected to have good growth potential after its launch.

 

The Study is led by top oncologist Professor Wu Yilong, Chairman of the Chinese Society of Lung Cancer and standing member of the Chinese Society of Clinical Oncology ("CSCO"). The first batch of participants have been enrolled prior to this announcement. 

 

Previously, U.S. Phase I clinical trial of Pirotinib has been completed in three renowned cancer research centers, with periodic results published in the 2017 American Society of Clinical Oncology ("ASCO") annual meeting. (ASCO is the largest professional organization for physicians and oncology professionals).

 

Participants have manifested desirable pharmacokinetic properties and drug response, with good safety profile and side-effects proved tolerable. Preclinical in intro and in vivo studies have demonstrated that Pirotinib suppressed the growth of certain types of EGFR mutation induced-NSCLC that were irresponsive to target drug treatments available. 

 

Receiving clinical trial approval from the U.S. FDA and the completion of U.S. Phase I study have expedited the progress of clinical trials in China by providing with supportive data. Phase III Clinical Trial is expected to commence in the second half year of 2019.

 

EGFR mutation can cause various types of malignant including tumor lung cancer, stomach cancer, esophageal cancer while effective treatment remains elusive. In China, lung cancer ranks highest in malignant tumors in terms of mortality and morbidity. 

 

According to Globaldata, the global market capacity of NSCLC reached US$20.9 billion in 2016 and is expected to rise at double-digit CAGR in the next few years. Pirotinib, once proved to be able to effectively suppress the growth of such mutation, will enjoy considerable growth potential.

 

Sihuan Pharmaceutical has been dedicating considerable resources and efforts in innovative drug R&D since as early as 2008. Its well-established innovative drug R&D platform brings together experts on various areas and aspects of innovative drug R&D. 

 

With extensive working experiences in multi-national pharmaceutical companies, the Group's innovative drug R&D team ranks among the top in China in terms of integrated R&D capabilities. In 2017, the Group's R&D expenditure accounted for approximately 11% of its sales revenue, exceeding industry average.

 

Dr. Che Fengsheng, Chairman and CEO of Sihuan Pharmaceutical, said, "after 10 years of continuous dedication of substantial resources and efforts, Sihuan Pharmaceutical now possesses a well-developed innovative drug R&D platform, with a strong product pipeline focusing on therapeutic areas with considerable unmet clinical demand, including CCV, oncology, diabetes, non-alcoholic liver diseases and pain relief. 

 

The development of Pinotrinib has achieved sound progress that application for production approval will complete in 2021 the earliest. 

 

The exciting progress speaks for our international-level R&D capabilities. Looking ahead, Sihuan Pharmaceutical is striving forward with focus and determination. We have implemented a series of internal adjustments with the aim to 'strengthen R&D capabilities, optimize product resources and accelerate market expansion'. 

 

The Group is entering the next stage of development, with view to create better and sustainable return for its shareholders."

 

Sihuan Pharmaceutical is also equipped with a well-established generic drug R&D team and platform, which has successfully developed a number of first-to-market generic drugs in its current product portfolio. As disclosed in the 2017 annual report, Sihuan Pharmaceutical selected a few oral solid form drugs for bioequivalence tests, such as metformin hydrochloride tablet (鹽酸二甲雙胍片). 

 

Upon the passing of bioequivalent test in the near future, it will become another growth driver of the Group. Sihuan Pharmaceutical's generic drug pipeline includes CCV drug vinpocetine injection (長春西汀注射液), rivastigmine hydrogen tartrate capsules (重酒石酸卡巴拉汀膠囊), levetiracetam tablets (左乙拉西坦片), amlodipine besylate tablets (苯磺酸左氨氯地平片), levetiracetam injection (左乙拉西坦注射液) , etc. Its strategic diversity will contribute to the Group's product resources in the short-, mid- and long-term.

 

About Sihuan Pharmaceutical Holdings Group Ltd.

Founded in 2001, Sihuan Pharmaceutical Holdings Group Ltd. has become the largest cardio-cerebral vascular drug manufacturer in China's prescription drug market by market share since 2007. The Group was the sixth largest pharmaceutical company in terms of hospital purchase in the Chinese prescription drug market in 2017. 

 

Sihuan Pharmaceutical is an integrated corporate with its own production, R&D and marketing capacities. The success of the Group can be attributed to its differentiated and proven sales and marketing model, extensive nationwide distribution network, diversified product portfolio, and strong R&D capabilities. 

 

The Group's current products encompass the top five medical therapeutic areas in China: cardio-cerebral vascular system, central nervous system, metabolism, oncology and anti-infectives. 

 

The Group has begun its innovative drug R&D since 2008 and now possesses a well-established innovative drug R&D platform, which is supported by 400 R&D experts and focuses in therapeutic areas with considerable unmet clinical demand, including CCV, oncology, diabetes, non-alcoholic liver diseases and pain relief. (MO).