Business Wire

GUANGZHOU, China -- May 16, 2023

HiST Pharma through its wholly-owned Psoriasis Research Institute of Guangzhou
(PRIG) announces today that the U.S. Food and Drug Administration (FDA) has
approved its Investigational New Drug (IND) TC Cream to launch a U.S.-based
multicenter Phase III clinical study to treat patients with psoriasis
vulgaris, following a previously completed Phase II^b trial (NCT03372811).

“The initiation of a Phase III clinical trial for our IND, approved by the
FDA, is another key milestone for the company in the final stage of our
world’s first botanical new drug development following a successful Phase II^b
trial for the treatment of psoriasis." – Liping Yang, CEO of HiST Pharma

The upcoming randomized, double-blind, vehicle-controlled, multicenter study
aims to demonstrate the superiority of a world first-in-class
naturally-occurring botanical new drug over the vehicle in treating psoriasis
vulgaris in a large U.S. population, in terms of efficacy and long-term
safety.

“The initiation of a Phase III clinical trial of our IND in the U.S. is
another key milestone for the company in the final stage of our world’s first
botanical new drug development. It is based on a successful Phase II^b trial
and benefits from an earlier multicenter clinical trial of an approved new
drug by the National Medical Products Administration (NMPA) in China for the
treatment of psoriasis,” said Liping Yang, Chief Physician, Managing Director
of PRIG, and CEO of HiST Pharma. “Our IND, TC Cream, offers a new topical
option to treat psoriasis patients with breakthrough therapy targeting
multiple autoimmune signaling pathways, aiming to address patients’ unmet
medical needs and improve their long-term quality of life. With the clinical
clearance from the FDA, we are one step closer to bringing TC to benefit
millions of patients affected by this debilitating disease. We hope that TC
will become the world’s first botanical drug serving as a first-line topical
treatment for psoriasis and the third botanical drug ever approved for
marketing by the FDA.”

HiST Pharma is planning to continue its global licensing strategy with biotech
pharma partners to further leverage the product's market potential.

About PRIG

Psoriasis Research Institute of Guangzhou (PRIG), a wholly-owned research
institute of HiST Pharma, was founded in 2008 in Guangzhou, China. PRIG has
been developing TC, a botanical-based small-molecule drug since 2008. Compared
to the existing therapeutic drugs, TC has a novel and different mechanism to
treat psoriasis vulgaris and clinical treatment characteristics of rapid
onset, good efficacy, and minimal side effects.

In its Phase II^b clinical study in the U.S., NCT03372811, TC demonstrated its
superior efficacy over the vehicle under an 8-week regimen, and an excellent
safety and tolerability profile owning to its multi-target and multi-system
immunomodulation property that simultaneously promotes anti-inflammatory and
blocks pro-inflammatory mediators. PRIG is currently preparing to launch the
Phase III study in the U.S.

HiST Pharma

  * Headquarter: Guangzhou, China

  * Website:www.HiSTPharma.com



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Contact:

For further information about PRIG / HiST Pharma:
Prof. Liping Yang, Managing Director and CEO
Tel: +86 20-32215437
Email: lpyang@histpharma.com