Huadong Medicine Inks $1.8B Deal for Global First Oral Edaravone Tablet TTYP01, NDA Submission Imminent

On July 15, Huadong Medicine issued an announcement stating that its wholly-owned subsidiary, Zhongmei Huadong, has entered into a strategic cooperation agreement with Auzone Biopharma, securing exclusive rights in China for the development, registration, manufacturing, and commercialization of all indications for TTYP01 tablets (Edaravone Tablets), an improved new drug in oral edaravone formulation.

According to the terms of the agreement,Auzone Biological will receive an upfront payment of RMB 100 million, with development, regulatory, and commercial milestone payments of up to RMB 1.185 billion., with registration milestone payments and sales milestone payments not exceeding RMB 400 million and RMB 785 million, respectively, as well as tiered net sales royalties reaching up to double digits.

Huadong Medicine will be responsible for the development, registration, manufacturing, and commercialization of TTYP01 tablets in the licensed territory. Auzone Bio will continue to be responsible for the development and commercialization of TTYP01 tablets in other regions.

TTYP01 Tablets are an improved new drug independently developed by Auzone Biology. Its active ingredient, edaravone, is an antioxidant stress neuroprotective agent that inhibits oxidative damage to brain cells, vascular endothelial cells, and nerve cells by scavenging free radicals and suppressing lipid peroxidation.

As the world’s only oral edaravone tablet, TTYP01 Tablets offer improved patient compliance and convenience, covering both the acute and recovery phases of stroke, and are expected to deliver greater clinical benefits to a broad population of stroke patients. Furthermore, TTYP01 Tablets are simultaneously expanding their indications to include autism spectrum disorder (ASD) in children, amyotrophic lateral sclerosis (ALS), Alzheimer’s disease (AD), and acute mountain sickness.

Currently,TTYP01 tablets have completed Phase I clinical trials in China and Australia, respectively. The domestic Phase III clinical study for the indication of acute ischemic stroke (AIS) has been completed, with the New Drug Application (NDA) expected to be submitted in Q4 2024.The indication for amyotrophic lateral sclerosis (ALS) has been granted Orphan Drug Designation by the FDA. The FDA has approved that the product may file for marketing approval upon completion of bioequivalence (BE) studies, with an Abbreviated New Drug Application (ANDA) expected to be submitted in the United States by the end of 2024. For the autism spectrum disorder (ASD) indication in children, a New Drug Application (NDA) is expected to be filed in 2024 after the completion of Phase II clinical trials. For the Alzheimer’s disease (AD) indication, Phase II clinical research is currently underway, with an Investigational New Drug (IND) application expected in 2024.

The results of the domestic Phase III clinical trial of TTYP01 tablets showed that the proportion of subjects with a modified Rankin Scale (mRS) score of 0–1 on Day 90 was significantly higher in the TTYP01 tablet group than in the placebo group, with statistical significance, thereby meeting the primary endpoint; furthermore, the safety profile was favorable.

According to the announcement, compared with a 14-day in-hospital regimen of edaravone injection, TTYP01 tablets can reduce the consumption of medical resources and are suitable for long-term self-administration by patients. A 28-day treatment course is expected to achieve free radical scavenging, thereby reducing tissue damage and cerebral edema, improving neurological function, and alleviating patient symptoms. Existing studies have shown that prolonged medication duration is beneficial for the prevention and treatment of post-stroke cognitive impairment and motor dysfunction.

According to Citeline’s analysis, the drug is projected to reach peak sales of $300 million in the U.S. market after its launch.

Currently, innovative drugs have become the most important drug development field for Huadong Medicine. According to public information, Huadong Medicine currently has 111 projects under research and development, among which 73 are innovative products and biosimilar projects. In its announcement, Huadong Medicine mentioned that it has made forward-looking in-depth layouts around several strategic areas such as ADC (Antibody-Drug Conjugates), GLP-1 (Glucagon-Like Peptide-1), autoimmune diseases, industrial microbiology, and medical aesthetics. Adhering to innovation-driven development as the main strategic theme, Huadong Medicine regards innovative drugs as the foundation and direction for building future core competitiveness, focusing on the layout and development of new products with outstanding clinical value in the fields of major diseases and chronic conditions.

This strategic focus on innovative drugs is also reflected in its financial report. The report shows that in 2023, the company’s R&D investment in the pharmaceutical manufacturing segment (excluding equity investments) amounted to RMB 2.293 billion, a year-on-year increase of 23.67%. Of this, direct R&D expenditures totaled RMB 1.600 billion, up 33.74% year on year, accounting for 13.10% of the revenue from the pharmaceutical manufacturing business.

According to incomplete statistics from Arterial New Medicine, Huadong Medicine engaged in a total of 13 external collaborations between 2021 and 2024 (excluding commercial promotion partnerships). The largest upfront payment in a license-in deal was for the collaboration on the ADC drugs HDP-101 and HDP-103 with Heidelberg Pharma in 2022. Huadong Medicine subscribed to publicly issued shares of Heidelberg Pharma at €6.44 per share and acquired part of the existing equity from current shareholders, including the dievini Fund, for a total amount of €105 million. As a result, Huadong Medicine holds a total of 35% equity in Heidelberg Pharma, becoming its second-largest shareholder.

 Huadong Medicine External Cooperation | VCBeat New Medicine Graphics

This transaction marks Huadong Medicine’s first move in 2024, further strengthening its portfolio in the cardiovascular and cerebrovascular therapeutic areas. Public information indicates that Huadong Medicine currently has three drug candidates in this field, all acquired through licensing collaborations. The most advanced among them is TTYP01 tablets, recently licensed from Auzone Biologics.

According to Huadong Medicine’s Q1 2024 financial report released in April, the company reported operating revenue of RMB 10.411 billion (+2.93%), net profit attributable to shareholders of the parent company of RMB 862 million (+14.18%), and net profit attributable to shareholders of the parent company after deducting non-recurring gains and losses of RMB 838 million (+0.66%). Among these, Zhongmei Huadong, the core subsidiary in the pharmaceutical industrial segment, maintained a stable growth trend in its overall operations, achieving operating revenue (including CSO business) of RMB 3.399 billion, a year-on-year increase of 10.53%; and consolidated net profit of RMB 751 million, a year-on-year increase of 11.67%. Meanwhile, driven by continuous R&D innovation, Huadong Medicine has established a pipeline of global first-in-class novel drugs in its three core therapeutic areas—oncology, endocrinology, and autoimmune diseases—and has formed three distinctive R&D portfolios focused on ADCs, GLP-1, and topical formulations.