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 - Media OutReach - 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.