Pharnext Announces PXT3003 was Granted Priority Review by the China Food and Drug Administration

PARIS–(BUSINESS WIRE)–Regulatory News:

(Paris:ALPHA) (FR0011191287 – ALPHA), a
biopharmaceutical company pioneering a new approach to the development
of innovative drug combinations based on big genomic data and artificial
intelligence, today announced that PXT3003 was granted priority review
for Charcot-Marie-Tooth Type 1A disease (CMT1A) by the China Food and
Drug Administration (CFDA).

Pharnext’s first-in-class PLEODRUG™ PXT3003 is currently in a Phase 3
clinical trial in Europe and the United States, with results expected
before the end of 2018. PXT3003, developed using Pharnext’s R&D platform
PLEOTHERAPY™, is a novel oral fixed-low dose combination of baclofen,
naltrexone and sorbitol, with EMA and U.S. FDA Orphan Drug Designation.

GeneNet Co, Ltd, a joint venture between Tasly and Pharnext, owns the
commercialization rights for PXT3003 for CMT1A in Greater China
(Mainland China, Hong Kong, Taiwan, and Macau), as well as exclusive
license rights to all PXT3003 patents applied for and authorized in
Greater China.

In December 2017, GeneNet applied for clinical approval for PXT3003 to
be registered as an imported pharmaceutical in China. PXT3003’s
inclusion in the priority review process will greatly shorten the
waiting time for clinical approval and also expedite registration as an
imported pharmaceutical.

“We are pleased that PXT3003 has been identified as a priority by the
CFDA, and that its fast-track status will decrease the waiting time for
the drug’s approval,” said Prof. Daniel Cohen, M.D., Ph.D.,
Pharnext’s Co-Founder and CEO

About Pharnext

Pharnext is an advanced clinical-stage biopharmaceutical company
developing novel therapeutics for orphan and common neurodegenerative
diseases that currently lack curative and/or disease-modifying
treatments. Pharnext has two lead products in clinical development.
PXT3003 is currently in an international Phase 3 trial for the treatment
of Charcot-Marie-Tooth Type 1A disease and benefits from orphan drug
status in Europe and the United States. The results of this trial are
expected in the second half of 2018. PXT864 has generated positive Phase
2 results in Alzheimer’s disease. Pharnext has developed a new drug
discovery paradigm based on big data genomics and artificial
intelligence: PLEOTHERAPY™. The Company identifies and develops synergic
combinations of drugs called PLEODRUG™ offering several key advantages:
efficacy, safety and robust intellectual property. The Company was
founded by renowned scientists and entrepreneurs including Professor
Daniel Cohen, a pioneer in modern genomics, and is supported by a
world-class scientific team.

Pharnext is listed on Euronext Growth Stock Exchange in Paris (ISIN
code: FR0011191287).

For more information, visit

About Tasly

Tasly Pharmaceutical Group Co., Ltd. was listed on the Shanghai Stock
Exchange in August 2002 (Stock Code 600535). The company concept is “To
share the joy of health with all” and the company mission “To improve
human life and quality of life.” Tasly is committed to promoting the
integration of Traditional Chinese Medicine (TCM) with modern medical
and pharmaceutical technologies. It is also committed to building the
first international brand of modernized TCM. “To become the global
innovation leader of modern TCM and the scientific standard maker of
modern TCM” is our target. To achieve this goal, Tasly will strive to
bring modernized TCM to international pharmaceutical standards. To
support its development strategy of “Comprehensive
Internationalization,” Tasly has set up a complete manufacturing chain
which respects international guidelines and exploits intelligent
manufacturing systems. Based on its “Two Wheels of Innovation and
Capitalization” strategy, Tasly has developed several core competitive
advantages, such as its R&D model, a multi-level product system, a
multi-dimensional patent protection system and a commercial and
marketing network.


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