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

San Diego, CA, USA – June 4, 2018 – HUYA Bioscience International (HUYA), the leader in accelerating global development of China’s pharmaceutical innovations, today announced it is at a key stage in the company’s development of HBI-8000, HUYA’s lead novel epigenetic drug with important immunomodulatory properties. HUYA is conducting a Phase 2 trial of HBI-8000 in the US, investigating efficacy and safety in combination with nivolumab for the treatment of solid tumors. The ongoing Phase 2 study is an open label study of patients with advanced renal cell cancer, non-small cell lung cancer and melanoma.

“We are at an important milestone in the development of HBI-8000 as we test the compound’s ability to improve the clinical benefit of checkpoint inhibitors for the treatment of solid tumors” said Dr Mireille Gillings, HUYA’s CEO and Executive Chair. “The emerging data for the combination are encouraging, leading to our ultimate goal which is to harness the demonstrated immunomodulatory properties of HBI-8000 to improve the outcome for patients treated with immunological therapies.”

HBI-8000 is a member of the benzamide class of histone deacetylase (HDAC) inhibitors designed to block the catalytic pocket of Class I HDACs. Recent data show greatly expanded immunomodulatory properties which explain in greater depth the strong results now being seen in the clinic. HBI-8000 is an orally bioavailable, low-nanomolar inhibitor of cancer-associated HDAC enzymes with favorable pharmacology and safety profiles. Studies with human-derived tumor cell lines and animal tumor models have demonstrated that HBI-8000 inhibits the growth of many tumors via multiple mechanisms of action, including epigenetic regulation of tumor cell growth and apoptosis, immunomodulatory effects regulating antitumor activity, as well as repression of genes associated with drug resistance. HBI-8000 is approved in China for the treatment of peripheral T-cell lymphoma.

Dr Bob Goodenow, President, HUYA, said “We’ve targeted a significant improvement for the combination relative to nivolumab’s overall response rate, disease control rate and other clinical parameters to proceed to registration studies. Our results to date exceed expectations and clearly demonstrate the combination should be tested in a pivotal setting for the clinical benefit observed in our Phase 2 trial.”

About HUYA Bioscience International

HUYA Bioscience International is the leader in enabling and accelerating the global development of novel biopharmaceutical product opportunities originating in China. Extensive collaborations are established with Chinese biopharmaceutical, academic and commercial organizations to speed development and value creation in worldwide markets for China-sourced product candidates. With the largest Chinese compound portfolio covering all therapeutic areas, HUYA has emerged as the partner-of-choice for maximizing the value of biopharmaceutical innovation in China. HUYA has offices in the US, Japan, South Korea and eight strategic locations across China. With the largest team of scientists working with Chinese innovators, HUYA identifies and advances promising drug candidates globally. For more information please visit www.huyabio.com

Contact details:

Yiota Merianos
HUYA Corporate Communications
+1.858.353.1217
ymerianos@huyabio.com

San Diego, CA, USA – July 10, 2017 – HUYA Bioscience International, the leader in accelerating global development of China’s pharmaceutical innovations, today announced a strategic collaboration agreement with Suzhou BioTOP Technical Service Co., Ltd. (referred to as BioTOP). The collaboration will focus on promoting the development of biomedical innovations from companies and research organizations in Suzhou BioBay that help to meet the increasing demand to fill global pharmaceutical pipelines.

HUYA is the first company to have recognized China’s potential as an important source of new innovative preclinical and clinical stage compounds. The company accelerates the development and value creation for China-sourced novel biopharmaceutical compounds in worldwide markets. HUYA has already established over one hundred collaborations with leading universities and research institutes throughout China as a pioneer in licensing both preclinical and clinical stage compounds.

BioTOP, located in Suzhou BioBay, is a wholly state-owned subsidiary of BioBay. BioTOP endeavors to provide comprehensive and attentive services to innovative companies in life sciences. With its integrated software and hardware service platforms, BioTOP helps companies in BioBay to reduce R&D cost and accelerate the transformation and commercialization processes of R&D accomplishments.

The agreement combines the expertise of both HUYA and BioTOP to promote biomedical innovations with global market potential in the Yangtze River Delta region. Local pharmaceutical companies and research organizations in BioBay will have opportunities to access HUYA’s international pharmaceutical knowledge and network resources, as well as the HUYA team’s expertise in drug development and commercialization. In return, HUYA will have priority to evaluate certain research and development opportunities of these entities, and potentially co-develop them for global markets in the future.

“This partnership is an exciting strategic step given the knowledge sharing and synergies it will create between HUYA and BioTOP. Such cooperation will not only increase business opportunities for both sides, but also advance the development and globalization of East China’s pharmaceutical innovation,” said Clement Gingras, HUYA’s Chief Technology Officer and Chief Operating Officer Asia.

General Manager of BioTOP, Yongmei Li, also expressed confidence in this collaboration. “The rich resources of science and technology in Yangtze River Delta and the comprehensive services provided by BioTOP in early new drug development, combined with HUYA’s expertise in global development of innovative drugs will generate significant advantages to help many resident companies in BioBay that develop innovative drugs. We anticipate more new drug opportunities progressing towards global markets through this collaboration platform,” said Ms. Li.

About HUYA Bioscience International

HUYA Bioscience International is the leader in enabling and accelerating the global development of novel biopharmaceutical product opportunities originating in China. Extensive collaborations have been established with innovators to speed development and value creation in worldwide markets for China-sourced product candidates. With the largest Chinese compound portfolio covering all therapeutic areas, HUYA has emerged as the partner-of-choice for maximizing the value of biopharmaceutical innovation in China. HUYA’s lead immune-oncology product HBI-8000 is in registration trials in Japan for lymphoma and in clinical development in the U.S. for solid tumor indications. With the largest team of scientists working with Chinese innovators, HUYA develops promising drug candidates globally. For more information, please visit www.huyabio.com .

About BioTOP and BioBay

BioTOP Technical Service Co., Ltd., located in Suzhou BioBay, is a wholly state-owned subsidiary of BioBay, managing all the public platforms of BioBay. BioTOP provides analyses of drug and health product ingredients, GMP verification, supply chain management, technology training, biomaterial express and incubation for startups in life science. The primary mission of BioTOP is to become a one-stop life science partner of enterprises. For more information, please visit http://www.biotop.com.cn/?2 .

Suzhou BioBay is located in southwest of Suzhou Industrial Park (SIP), and is the key driver of life science innovation for SIP. More than 400 high-tech innovative companies covering drug discovery, medical device (including IVD), and biotechnology are located in BioBay, and more than 10000 scientists and professionals have come to join this dynamic innovative community. For more information, please visit http://en.biobay.com.cn .

Contact Details:

Clement Gingras
CTO and COO Asia
HUYA Bioscience International
+1 858.798.8800
cgingras@huyabio.com

Yung-Chih Wang, PhD, MBA
VP, Corporate Development China
HUYA Bioscience International
+1.858.798.8818
ywang@huyabio.com

San Diego, CA, USA – January 18, 2017 –HUYA Bioscience International (HUYA), the leader in accelerating the global development of China’s pharmaceutical innovations, announced today a strategic collaboration agreement with the Chinese Academy of Sciences Innovation and Investment Company (referred to as CAS Innovation). The collaboration will focus on developing and commercializing biomedical innovations discovered by leading scientists at CAS to meet the medical needs of patients around the world. Continue reading →

San Diego, CA, USA – December 14, 2016 – For the second straight year, HUYA Bioscience International (HUYA) was a proud sponsor of the Best New Drug category at the Annual Scrip Awards.

Dr. Mireille Gillings presented HUYA Bioscience’s Best New Drug Award to Sanofi Pasteur MSD, which was recognized for the launch of its new product, Dengvaxia (tetravalent dengue vaccine), a game-changing therapy for dengue fever. The award was presented at a ceremony at the Grosvenor House Hotel in London, UK, attended by over 500 industry leaders.

“Warmest congratulations to Sanofi Pasteur MSD on this well-deserved recognition of excellence,” said Dr. Mireille Gillings, CEO and Executive Chair of HUYA. “As HUYA fully understands, finding new sources of innovation is an essential role of our industry, as we improve the health and quality of life of patients.

In the Best New Drug category, the judges sought the small-molecule or biological product that was approved in its first market worldwide during the qualifying period that represented the best therapeutic advance in its area. The recipient was selected by a 15-member, independent industry experts from around the world.

Since it was founded in 2004, HUYA has advanced the global development of novel oncology and cardiovascular drugs licensed from China. The company was the first to leverage the Tripartite Cooperation between China, Japan and South Korea to use clinical data from China to initiate drug development for HUYA’s lead drug HBI-8000 in Japan for lymphoma. HBI-8000 is also advancing in several solid tumor indications in the U.S. HUYA’s drug has immunomodulatory properties which are important to the clinical development of immuno-oncology therapeutics.

About HUYA Bioscience International

HUYA Bioscience International is the leader in enabling and accelerating the global development of novel biopharmaceutical product opportunities originating in China. Extensive collaborations have been established with Chinese biopharmaceutical, academic and commercial organizations to speed development and value creation in worldwide markets for China-sourced product candidates. With the largest Chinese compound portfolio covering all therapeutic areas, HUYA has emerged as the partner-of-choice for maximizing the value of biopharmaceutical innovation in China.  With the largest team of scientists working with Chinese innovators, HUYA develops promising drug candidates globally. For more information, please visit www.huyabio.com

About the SCRIP Awards

The SCRIP Awards provide the industry with an opportunity to acknowledge and applaud its highest achievers across all parts of the value chain, and to recognize both corporate and individual achievement. For details, please visit www.scripawards.com

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

Recognized for Visionary Leadership Within Asia’s Pharmaceutical Industry

San Diego, CA, USA – March 24, 2016 –HUYA Bioscience International (HUYA) Founder and Executive Chair Mireille Gillings, Ph.D., has been named Pharma Executive of the Year at the BioPharma Industry Awards 2016. Presented in conjunction with the 9^th BioPharma Asia Convention 2016.

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Biopharma Company with Joint HQ in Shanghai & San Diego Commemorates a Decade of Innovation

Shanghai, China – March 22, 2016 –HUYA Bioscience International (HUYA) celebrated the 10th anniversary of the opening of its first offices in China with a gala dinner at the ‘M on the Bund’ restaurant in Puxi, Shanghai. Executives commemorated a decade of leadership in enabling and accelerating the global development of novel biopharmaceutical product opportunities originating in China.

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HBI-8000 granted orphan drug designation for peripheral T-cell lymphoma in Japan

San Diego, CA, USA – December 22, 2015 –HUYA Bioscience International (HUYA), Founder, CEO & Executive Chair, Dr. Mireille Gillings today announced that the Ministry of Health, Labour and Welfare (MHLW) granted HBI-8000 orphan drug designation in Japan for peripheral T-cell lymphoma (PTCL).

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Supports Prestigious Award Recognizing Excellence in Pharmaceutical Development

San Diego, CA, USA – December 3, 2015 –HUYA Bioscience International (HUYA) was a proud sponsor of the ‘Best New Drug’ category at the 11th Annual SCRIP Awards. Dr. Mireille Gillings was a finalist for ‘Executive of the Year’ and HUYA was a finalist for ‘Best Company in an Emerging Market’. These prestigious awards recognize excellence in the biopharmaceutical industry. HUYA CEO and Executive Chairman, Dr. Mireille Gillings, presented HUYA Bioscience’s Best New Drug Award to Novartis which was recognized for the launch of its new product Cosentyx (secukinumab), a therapy for psoriasis. The award was presented at a ceremony at the Grosvenor House Hotel in London, attended by over 300 industry leaders.

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Seoul Office Will Head Operations to Develop Korean Biopharmaceutical Innovation

Seoul, Korea – December 2, 2015 –HUYA Bioscience International (HUYA), the global leader in accelerating drug discovery and development of biopharma innovation originating in China, recently opened its first Corporate office in Korea. This continues to build on HUYA’s overall strategy to be the partner-of-choice for innovative pharmaceutical companies in emerging centers of excellence worldwide.

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