AKSO and Huadong Medicine Announce Strategic Collaboration to Develop and Commercialize AB002 in Asia Pacific Ex-Japan

– Huadong Medicine is granted from AKSO Biopharmaceutical an exclusive right to develop and commercialize AB002 in the Asia Pacific Ex-Japan region for solid tumors; AKSO Biopharmaceutical to receive up to 75 million USD upfront, R&D funding, potential regulatory and commercial milestone payments

– Strategic partnership accelerates AB002’s development as a first-in-class and potentially first-to-market novel molecule

– Enables AKSO to access a critical and attractive market via Huadong Medicine’s expertise and networks while augmenting Huadong Medicine’s portfolio of innovative drug candidates

LOS ANGELES & LONDON & HANGZHOU, China–(BUSINESS WIRE)–AKSO Biopharmaceutical, Inc. (“AKSO”), a global biopharmaceutical company with an innovative and comprehensive approach to treat cancer, autoimmune disease, and genetic disorder, and Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (SZ.000963) (“Huadong Medicine”), a leading pharmaceutical company in Asia, today announced that the companies have entered into an exclusive collaboration to develop and commercialize AB002, a bi-functional fusion protein inhibiting immune checkpoint and activating natural killer (NK) cells for the treatment of solid tumors, in the Asia Pacific Ex-Japan region. AKSO will retain all rights to AB002 in the rest of the world.

This strategic collaboration enables AKSO to leverage Huadong Medicine’s leading expertise in clinical development, regulatory approval, and commercialization to access the second largest pharmaceutical market in the world, while augmenting Huadong Medicine’s portfolio of first-in-class innovative drug candidates and further cementing Huadong Medicine’s leadership position in the region.

“The strategic collaboration is an important milestone for AB002 as Huadong Medicine’s expertise and experience in drug development, and mature clinical and sales network will enable us to become the first to market in the critical region,” said Amato Giaccia, Ph.D., Senior Scientific Strategist and Chairman of AKSO. “AB002 is a first-in-class molecule that leverages AKSO’s proprietary DEEP platform to neutralize PD-L2 and PD-L1, while activating NK cells via an IL-15 agonist. This unique approach addresses the immune-suppressive environment frequently found in patients not responding to immune checkpoint inhibitors. Furthermore, AB002’s precision cell targeting ability promotes NK cell activation in the tumor microenvironment. We are excited to partner with Huadong Medicine to accelerate AB002’s development and deliver this innovative therapeutic to patients with unmet urgent needs.”

“AKSO Biopharmaceutical is a promising biopharmaceutical company innovating to treat cancer. AB002, which is a dual-target bi-specific fusion protein, represents the addition of an exciting cancer immunotherapy asset to Huadong Medicine’s increasing cancer therapy pipeline,” stated Dongzhou J. Liu, Ph.D., Chief Scientific Officer of Huadong Medicine. “The cancer patient population is substantial in China, with unmet medical needs. Leveraging Huadong Medicine’s R&D capabilities, we will work closely with AKSO Biopharmaceutical to accelerate the development of AB002 to benefit the cancer patients all over the world.”

Under the terms of the agreement, AKSO will be eligible to receive upfront and milestone payments of up to $75 million, as well as royalties from future product sales. Huadong Medicine will be responsible for clinical development, regulatory submissions and commercialization of AB002 in the region and jointly steer IND-enabling tasks with AKSO via the Joint Research Committee. AKSO will continue to be responsible for AB002’s development in the rest of the world.

AKSO is advised by Dragon Financial Partners Ltd. as financial advisor and Morrison Forrester LLP as legal counsel.

ABOUT AB002

AB002 is a late preclinical stage first-in-class bifunctional fusion protein comprising of a DEEP-engineered soluble PD-1 decoy receptor for immune checkpoint inhibition, and an IL-15 agonist for NK cell activation. AB002 traps PD-L2 and PD-L1 with ultra-high binding affinities, while activating NK cells with high precision and extended half-life.

ABOUT AKSO

AKSO Biopharmaceutical, Inc., is a late preclinical stage global biopharmaceutical company focused on the discovery and development of first-in-class therapeutics for the treatment of cancer, autoimmune diseases, and genetic disorder. Leveraging the proprietary DEEP engineering platform and deep knowledge in disease biology, AKSO has developed a portfolio of innovative drug candidates covering a wide range of modalities including decoy receptors, bispecific fusion proteins, antibody-drug conjugates, and precision gene editing therapies. For additional information, please visit www.aksobio.com.

ABOUT HUADONG MEDICINE

Huadong Medicine Co., Ltd. (SZ.000963) is a leading Chinese pharmaceutical company headquartered in Hangzhou, China. Founded in 1993, Huadong Medicine has fully integrated R&D, manufacturing, distribution, sales and marketing capabilities. Huadong Medicine’s product portfolio and pipeline are specialized in oncology, immunology, nephrology and diabetes. The Company’s annual revenue in 2020 exceeded 5 billion USD. Huadong Medicine has 11,000 employees among which 1,200 are dedicated to R&D. Huadong Medicine possesses one of the most extensive commercial coverage and marketing capabilities in China. ‘Patient Centered, Science Driven’ is Huadong Medicine’s value. For additional information, please visit www.eastchinapharm.com/en.

Contacts

INVESTOR RELATIONS AND MEDIA CONTACTS

AKSO Biopharmaceutical, Inc.
Rebecca Miao
[email protected]

Huadong Medicine
+86 571 8990 3300

[email protected]