Market Overview

CANbridge Life Sciences Receives Approval to Commence CAN017 Ib/III Trial in Esophageal Squamous Cell Cancer (ESCC) In China


CANbridge Life Sciences, a biopharmaceutical company developing Western
drug candidates in China and North Asia, announced that the China
National Drug Administration (CNDA) has approved the Investigational New
Drug (IND) application for a Phase Ib/III clinical study of CAN017 in
esophageal squamous cell cancer (ESCC). The Phase Ib/extension study is
a multicenter, open label study to evaluate the safety, tolerability,
pharmacokinetics and preliminary efficacy of CAN017 in combination with
chemotherapy as the second line treatment for patients with locally
advanced or metastatic esophageal squamous cell carcinoma (ESCC). ESCC
is the most prevalent form of esophageal cancer, with 50% of the cases
occurring in China. The CAN017 IND approval is a key milestone for
CANbridge and the second one this year, following the IND approval to
commence a trial in CAN008 in glioblastoma multiforme (GBM) in April.

CAN017 is an ErbB3 (HER3) inhibitory antibody humanized IgG1/κ ERBB3
inhibitory antibody that completed a first-in-human Phase I clinical
trial in patients with advanced solid tumors in US patients. In
preclinical work, CAN017 showed potential for the treatment of ESCC.
Additional preclinical work, in human cancer models, found Neuregulin 1
(NRG1) gene expression to be a promising biomarker, with the potential
to predict response to ERBB3 inhibition by CAN017.

"Standardized second-line therapy for advanced esophageal carcinoma is
not available so far," said Professor Lin Shen, Vice-President of
Beijing Cancer Hospital. "There is no drug approved as targeted therapy
for ESCC, which is prevalent among Chinese. It's necessary and pressing
to develop this investigational drug, with a defined target and
biomarkers, for such unique unmet medical needs in China."

"The CNDA approval to start our second trial in China in a single year
illustrates CANbridge's commitment to bring promising treatments to
underserved populations and our emergence as a commercial-stage
biopharmaceutical company with a strong clinical pipeline," said James
Xue, PhD, MBA, CANbridge Chairman, President and CEO. "We plan to
commence our multi-center clinical trial in CAN017 in esophageal
squamous cell cancer this year, as well as to continue to explore other
potential CAN017 indications which show promise preclinically. "

About Esophageal Squamous Cell Cancer (ESCC)

Esophageal squamous cell cancer (ESCC) is the most common form of
esophageal cancer. According to the World Health Organization, it is
also the eighth-most common cancer globally, with over 450,000 new cases
diagnosed each year. However, ESCC occurs predominantly in China, which
is widely believed to have 50% of the cases, as well as in other parts
of Asia. Most esophageal cancer treatments address the adenocarcinoma
form of the cancer, most prevalent form in the West, leaving ESCC
patients with few options.

About CANbridge Life Sciences

CANbridge Life Sciences, Ltd. is a clinical-stage bio-pharmaceutical
company accelerating development and commercialization of specialty
healthcare products for serious and critical medical conditions in China
and North Asia (Korea and Taiwan). CANbridge develops partnerships with
Western bio-pharmaceutical companies with clinical-stage pharmaceutical,
medical device or diagnostic products that are either unavailable in
China/North Asia, or address medical needs that are underserved in the
region. CANbridge also licenses, or obtains exclusive rights to
commercialize, drug and device products that are approved in their home
markets for commercialization in China and North Asia.

CANbridge has exclusive rights to develop and commercialize Puma
Biotechnology's NERLYNX® (neratinib) in China, Taiwan, Hong Kong and
Macao (collectively, greater China), which was approved by the FDA, in
2017, for the extended adjuvant treatment of adult patients with
early-stage HER2-positive breast cancer following adjuvant
trastuzumab-based therapy, and which CANbridge is developing as CAN030.
CANbridge plans to target HER2-positive cancers, including breast and
gastric. CANbridge has a license with Apogenix to develop, manufacture
and commercialize immune-oncology therapy, APG101, which CANbridge is
developing as CAN008, for the treatment of glioblastoma multiforme (GBM)
in greater China. CANbridge received China National Drug Administration
(CNDA) approval to commence a Phase II/III Trial in GBM in mainland
China, which it expects to initiate later this year. CANbridge has a
world-wide license (ex-North America) to develop, manufacture and
commercialize AVEO Oncology's clinical-stage ErbB3 (HER3) inhibitory
antibody candidate AV203, which it will develop as CAN017. CANbridge
also has an agreement with EUSA Pharma to commercialize Caphosol® in
China for the prevention and treatment of oral mucositis caused by
cancer treatments. Caphosol was approved for commercialization by the

Led and backed by a highly-seasoned executive team, with extensive
Chinese drug development experience, CANbridge has the capability to
select, acquire, develop and commercialize future therapeutics and
diagnostics targeting the unmet medical needs of Chinese and East Asian
patients with serious or critical conditions.

CANbridge is privately-held and headquartered in Beijing, China. For
more on CANbridge Life Sciences, please go to

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