HUYA Bioscience International Announces the Successful Completion of Phase 1 Trial of HBI-3000

Phase 2 trial will test the unique multi-channel ion blocker in acute atrial fibrillation

San Diego, CA, USA – February 28, 2020 HUYA Bioscience International, the leader in accelerating global development of China’s pharmaceutical innovations, has presented the results of a Phase I study of HBI-3000, a novel drug for cardioversion of atrial fibrillation (AF).

The study, conducted in the UK, was a single ascending dose trial of intravenous HBI-3000 in healthy subjects. The objective was to establish the safety, tolerability and pharmacokinetics with electrocardiogram (ECG) monitoring. The data were presented during a poster session at the American Heart Association 2019 annual meeting. A copy is available via the HUYA Bioscience website (www.huyabio.com).

HBI-3000 is a multi-ion channel blocker with in vitro inhibitory effects on INa-Peak, INa-Late, ICa,L and IKr being developed for the cardioversion of recent onset AF. AF is a serious condition that affects more than 3.5 million patients in the US and 30 million patients worldwide. There is a significant need for safer and more effective pharmacological interventions to treat AF, as current treatments have poor safety and efficacy profiles and the alternative, electrical cardioversion, requires fasting and sedation and can be anxiety provoking for patients.

Dr Jay Mason, University of Utah, commented “HBI-3000 was well tolerated with no dose limiting adverse events or arrhythmias observed. These data demonstrate that HBI-3000 is a potent inhibitor of multiple cardiac ion channels that play a role in onset and maintenance of AF, exhibiting linear pharmacokinetic (PK)-pharmacodynamic (PD) relationships. It should now be further investigated for its ability to pharmacologically convert patients with recent onset AF back into a normal rhythm”.

“The successful completion of our Phase 1 study is a very significant milestone in our journey to identify a new and improved treatment for patients with AF.” said Dr Mireille Gillings, CEO and Executive Chair of HUYA Bioscience. “Based on the supportive PK/PD and safety results in this study in healthy subjects, HBI-3000 is now entering Phase 2 clinical development in patients with recent onset AF”.

About HBI-3000
HBI-3000 is a multi-ion channel blocker with in vitro inhibitory effects on INa-Peak, INa-Late, ICa,L and IKr being developed by HUYA Bioscience International for the conversion of recent onset atrial fibrillation (AF). The drug’s preclinical and clinical pharmacology supports the potential of HBI-3000 to restore sinus rhythm in AF. The drug has demonstrated a low risk for proarrhythmia in preclinical testing.

About HUYA Bioscience International
HUYABIO is the leader in enabling and accelerating the global development of novel biopharmaceutical product opportunities originating in China. The Company has emerged as the partner-of-choice for maximizing the value of innovation in China. With the largest team of scientists working with Chinese innovators, HUYABIO identifies and advances promising drug candidates globally and has offices in the US, Japan, South Korea and China.

Contact details:
Yiota Merianos,
Corporate Communications
+1.858.353.1217
ymerianos@huyabio.com
www.huyabio.com

HUYA Bioscience International Appoints Meiji Seika Pharma as Exclusive Distributor For HBI-8000 in Japan and Other Asian Countries

Meiji Seika Pharma to Commercialize HUYABIO’s Product in Lymphoma

San Diego, CA, USA – January 8, 2020 – HUYA Bioscience International CEO & Executive Chair, Dr. Mireille Gillings announced the appointment of Meiji Seika Pharma (Meiji) as an exclusive distributor for its lymphoma product, HBI-8000, in Japan. Meiji also acquired exclusive rights for HBI-8000 in Japan, South Korea, Thailand, Malaysia, Indonesia, Philippines, Vietnam and Singapore. The drug, an epigenetic immunomodulator, is the first approved oral class I-selective histone deacetylase inhibitor which is now in various stages of development globally for Peripheral T-Cell Lymphoma (PTCL) and Adult T-Cell Leukemia (ATL) in Japan and solid tumors in the United States. Increased excitement has been generated by studies that show that HBI-8000 produces cumulative effects over time that increase the receptivity of cancer cells to immunologic therapy.

The product has orphan drug designation for PTCL granted by Japan’s Ministry of Health, Labor and Welfare. HUYABIO will complete the development of HBI-8000 for PTCL and ATL in Japan for commercialization by Meiji who will hold exclusive sales and marketing rights. Meiji will pay HUYABIO an upfront and milestones plus royalties on net sales. HUYABIO will manufacture and supply the product to Meiji for initial commercialization.

“This collaboration aligns with Meiji’s R&D commitment to oncology to develop new drugs to fulfil unmet needs of patients worldwide. By continually improving our R&D process with innovation, Meiji brings high-value and high-quality drugs to market quickly. Meiji and HUYABIO will cooperate to commercialize HBI-8000, for the benefit of cancer patients” said Daikichiro Kobayashi, President and Representative Director of Meiji Seika Pharma Co, Ltd.

“We are delighted to enter into this partnership with Meiji to bring HBI-8000 to patients with PTCL or ATL. We also look forward to advancing the development of our drug based on its immunomodulatory properties” said Dr. Mireille Gillings. “The agreement reinforces our vision to leverage assets licensed from China for global development and commercialization. Meiji Seika Pharma’s strong position in hematologic malignancy will help ensure the drug’s success in the Japanese market.”

About HBI-8000
The novel epigenetic drug, HBI-8000, is a member of the benzamide class of histone deacetylase inhibitors, which regulate gene expression through histone modification, which enables the efficacy of increasing other cancer agents such as checkpoint inhibitors.

The company was the first to leverage the Tripartite Agreement between China, Japan and South Korea, which allowed Chinese clinical data to be leveraged in the other two countries. Based on clinical results, the Japanese Pharmaceutical and Medical Devices Agency allowed accelerated development of this drug in lymphoma.

About HUYA Bioscience International
HUYABIO is the leader in enabling and accelerating the global development of novel biopharmaceutical product opportunities originating in China. The Company has emerged as the partner-of-choice for maximizing the value of innovation in China. With the largest team of scientists working with Chinese innovators, HUYABIO identifies and advances promising drug candidates globally and has offices in the US, Japan, South Korea and China.

About Meiji Seika Pharma Co., Ltd.
In order to protect and improve people’s health and lives, Meiji Seika Pharma, as a “Speciality and Generic Pharmaceuticals Company,” runs its pharmaceutical business in the two main fields, infectious disease and central nervous system disorders, as well as generic drugs. Meiji Seika Pharma strives to respond to diversified medical needs and contributes to the well-being of people worldwide.

Contact details:
Bob Goodenow, Ph.D.
President
HUYA Bioscience International
+1.858.342.2430
bgoodenow@huyabio.com
www.huyabio.com