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

HUYA Bioscience International Licenses Clinical Stage Anti-Arrhythmic Compound From The Shanghai Institute Of Materia Medica

San Diego, USA and Shanghai, China – October 2, 2007 — HUYA Bioscience International (HUYA), a rapidly expanding biopharmaceutical company focused on the development of key disease-fighting drugs sourced from China, announced today that it has licensed a novel clinical stage anti-arrhythmic compound from the prestigious Shanghai Institute of Materia Medica (SIMM), Chinese Academy of Sciences. Read more

HUYA Bioscience International And Chipscreen Biosciences Initiate A Phase I Clinical Cancer Trial

San Diego, USA and Shenzhenm China – May 24, 2007 — HUYA Bioscience International, LLC and Chipscreen Biosciences Ltd. announced today that a Phase I clinical trial has been initiated in China with the compound Chidamide (CS055) /HBI- 8000, an investigational cancer compound. HUYA holds exclusive rights to the compound (HBI-8000) worldwide outside of China, while Chipscreen maintains rights in China. The Phase I clinical trial is designed to assess the safety, tolerability and pharmacokinetics of the compound. Read more

HUYA Bioscience Licenses Chidamide Cancer Compound from Chipscreen Biosciences

San Diego USA and Shenzhen, China – March 6, 2007 — HUYA Bioscience International, LLC, announced today that it has exclusively licensed worldwide rights outside China to the cancer compound chidamide from Shenzhen Chipscreen Biosciences Ltd.
Chidamide, is an investigational cancer compound currently approved to initiate a Phase I clinical trial in China. Read more

Organon Partners With HUYA To Identify And Develop Chinese Biopharmaceuticals

Collaboration looks for opportunities to expand the Organon biotech research programs and facilitate links with China’s biotech industry

Oss, The Netherlands and San Diego, USA – January 9, 2007 — Organon, the human healthcare business of Akzo Nobel (Nasdaq: AKZOY), announced today that it has signed a collaboration agreement with HUYA Bioscience International, LLC, (HUYA) to search for new, proprietary biopharmaceuticals or pharmaceutical compounds. As part of this collaboration, Organon has acquired an equity interest in HUYA, a biopharmaceutical company focused on developing Chinese biopharmaceutical products.

HUYA, with offices in San Diego and Shanghai, identifies, licenses and develops Chinese drug candidates for commercialization in Western markets. Under the collaboration agreement, HUYA will support Organon in the sourcing and development of pharmaceutical or biopharmaceutical compounds in three specific therapeutic areas.

“This is an important strategic opportunity for Organon. It is consistent with our research strategy to forge closer links with China’s highly skilled and motivated scientists and significantly expands our own ongoing biotech research programs and capabilities,” said David Nicholson, Executive Vice President Research and Development at Organon “We are very excited by this investment and the prospect of closely collaborating with HUYA.”

Mireille Gingras, President and Chief Executive Officer of HUYA added, “We are delighted to share the Organon knowledge and harness their extensive expertise in drug development in three specific therapeutic areas. We believe this collaboration is the first one between a biopharmaceutical and biotech company to jointly identify and develop investigational drugs in China. HUYA is highly experienced and uniquely well positioned with our large network of life science contacts and operating history in China to capitalize on the emerging biotech industry there.

“No financial details of the transaction were disclosed. The announcement follows other research collaborations that Organon has entered into with other leading Chinese biotech companies such as Shanghai Genomics and HD Biosciences in the last year.

About Organon
Organon – with shared head offices in Roseland, NJ, USA and Oss, The Netherlands – creates, manufactures and markets innovative prescription medicines that improve the health and quality of human life. Through a combination of independent growth and business partnerships, Organon strives to remain or become one of the leading biopharmaceutical companies in each of its core therapeutic fields: fertility, gynecology, anesthesia and neuroscience. Research areas also include immunology and oncology.

Organon products are sold in over 100 countries, of which more than 60 have an Organon subsidiary. Organon is the human health care business unit of Akzo Nobel.

About HUYA
HUYA, with offices in San Diego and Shanghai, capitalizes on the explosive growth of the biotechnology industry in China. HUYA identifies, licenses and develops promising Chinese pharmaceuticals for commercialization in Western markets. Using its management team and advisors, HUYA lowers the product development risk through the comprehensive sourcing of proprietary preclinical and early clinical stage pharmaceuticals from China. HUYA partners the development of such innovative investigational pharmaceuticals with biotech companies in China so that the initial clinical research is performed in China. Later clinical development is expected to be completed in the United States and Europe. Further information about the company is available at www.huyabio.com.

Organon Safe Harbor Statement*
This press release may contain statements which address such key issues as growth strategy, future financial results, market positions, product development, pharmaceutical products in the pipeline, and product approvals of Organon. Such statements should be carefully considered, and it should be understood that many factors could cause forecasted and actual results to differ from these statements. These factors include, but are not limited to, price fluctuations, currency fluctuations, progress of drug development, clinical testing and regulatory approval, developments in raw material and personnel costs, pensions, physical and environmental risks, legal issues, and legislative, fiscal, and other regulatory measures. Stated competitive positions are based on management estimates supported by information provided by specialized external agencies. For a more comprehensive discussion of the risk factors affecting our business please see our Annual Report on Form 20-F filed with the United States Securities and Exchange Commission, a copy of which can be found on the Akzo Nobel corporate website www.akzonobel.com.

* Pursuant to the U.S. Private Securities Litigation Reform Act 1995.

Contact
HUYA Bioscience International, LLC
USA:
Mireille Gingras, Ph.D.
President and Chief Executive Officer
HUYA Bioscience International, LLC
(858) 350-6265
mgingras@huyabio.com
www.huyabio.com

China:
Wen Chen, M.S., M.B.A.
Director Business Development
HUYA Bioscience International
wchen@huyabio.com

Organon
Monique Mols
Director Media Relations
NV Organon
+31-412-665440
monique.mols@organon.com

Media Contact:
Karen Sparks
(858) 455-5500
karen@mentus.com