On February 9, 2022 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, reported 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 (Press release, AKSO Biopharmaceutical, FEB 9, 2022, View Source [SID1234607929]).

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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.