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Aceso Life Science Group Limited
(formerly known as Hao Tian Development Group Limited ˂೯ණྠϞࠢʮ̡)
(Incorporated in the Cayman Islands with limited liability)
(Stock Code: 00474)
MEMORANDUM OF UNDERSTANDING IN RELATION TO LICENSING OF
DRUG FOR TREATMENT OF PAIN
This announcement is made by the board of Aceso Life Science Group Limited (the ''Company'') on a voluntary basis.
The board is pleased to announce that the Company has signed a memorandum of understanding (the ''MOU'') with Scilex Holding, a Delaware corporation (''Scilex'') for an exclusive negotiation for a period of 90 days for:
(a) an exclusive license of Scilex SP-102 (SEMDEXA) (''SP-102''), a proprietary drug product of Scilex which is in pivotal Phase 3 trials in the United States with Fast Track status from the United States Food and Drug Administration (''FDA''), in the Mainland China, Hong Kong, Macau and Taiwan (the ''Greater China territory''); and
(b) the necessary data of preclinical research and clinical trials in support of the Company's application for license for import, manufacturing and sales of SEMDEXA or SP-102 in the Mainland China from Chinese National Medical Products Administration.
The MOU outlines the exclusivity between Scilex and the Company for the product development, manufacturing and commercialization rights to SP-102, a novel non-opioid injectable viscous therapeutic for the treatment of pain and sciatica in the Greater China territory. Based on the internal assessment, the expected total value of the exclusive license for the Greater China territory will be in the range of USD60 million to USD80 million.
INFORMATION ON THE PRODUCT
SEMDEXA or SP-102 is a sterile corticosteroid injectable viscous gel drug product containing dexamethasone sodium phosphate and a biologic excipient in a pre-filled glass syringe with a 2 mL deliverable volume. SEMDEXA or SP-102 which is in pivotal Phase 3 trials in the United States has received Fast Track status, which is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. It is a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain or sciatica and is developed to address the limitations associated with all the available corticosteroid epidural injections that are currently used off-label.
SEMDEXA or SP-102 if approved, could become the first FDA-approved safe and effective epidural steroid product with long-term patent protection, which would create significant market opportunity worldwide.
Based on the information provided by Scilex, any future potential competitors with an alternate formulation would be required to conduct extensive preclinical studies and costly clinical trials including comparative clinical trials before being able to file for approval. Subject to change in regulatory requirements and other conditions, SEMDEXA or SP-102 is in pivotal Phase 3 trials for chronic low back pain/sciatica with trial enrollment expected to be completed in first half of 2021 and topline results in the second half of 2021.
The Company believes that the consummation of the transactions under the MOU will deepen the cooperation and relationships between Scilex and the Company.
INFORMATION ON SCILEX AND SORRENTO
Scilex is a subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE) (''Sorrento'').
Based on the public information available, Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. Sorrento's multimodal multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (''G-MAB™library''), clinical stage immuno-cellular therapies (''CAR-T'' ), intracellular targeting antibodies (''iTAbs'' ), antibody-drug conjugates (''ADCs''), and clinical stage oncolytic virus (''Seprehvir™''). Sorrento's commitment to life-enhancing therapies for cancer patients is also demonstrated by their effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule in Resiniferatoxin (''RTX'') and ZTlido®.
By order of the board of directors of Aceso Life Science Group Limited
Fok Chi Tak
Hong Kong, 24 March 2021
As at the date of this announcement, the board of the Company comprises three executive directors, namely Mr. Xu Haiying, Dr. Zhiliang Ou, J.P. (Australia) and Mr. Fok Chi Tak; two non-executive directors, namely Dr. Wang Yu and Dr. Li Yao; and three independent non-executive directors, namely Mr. Chan Ming Sun Jonathan, Mr. Lam Kwan Sing and Mr. Lee Chi Hwa Joshua.