NEWARK, Del., July 15, 2026 /PRNewswire/ — Recently, ACROBiosystems has officially received the “Material Suitability Confirmation for Regenerative Medicine Products” (Certificate No.: 薬機審長発第47号) from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan for its GMP-grade Human IL-15 protein. This recognition further validates ACROBiosystems’ quality system and serves as an authoritative endorsement of its compliance capabilities and expertise in the core raw materials field of cell and gene therapy.

The confirmation is part of an official evaluation system established by the PMDA for key raw materials used in the production of regenerative medical products, such as CAR-T, CAR-NK, and TCR-T immunotherapy. Its core function is to enable developers to obtain official confirmation of the safety and compliance of raw materials early in the research and development process, thereby streamlining the evaluation of these materials when applying for clinical trials or marketing approvals from the PMDA, thus accelerating product development. To obtain this confirmation, several stringent conditions must be met: the product and its manufacturing process must not contain human or animal-derived components that require proof of compliance with the “Guidelines for Biological Raw Materials,” or must provide sufficient compliance evidence; the product must not contain physiological active substances, toxic substances, heavy metals, or other components that pose direct risks to the safety of clinical trial products; and the entire production process must have a sound quality management system in place to provide complete supply chain traceability and testing validation data.

The confirmation obtained by ACROBiosystems explicitly states that no human or animal-derived components requiring proof of compliance with biological raw material guidelines are used in the composition and preparation of this material, and the core active ingredient is recombinant human IL-15 protein (0.3 g/L), which fully meets the PMDA’s evaluation requirements in terms of safety.

As a key cytokine for high-quality immune cell culture and in vitro functional validation, IL-15 plays a crucial role in the preparation of CAR-T, CAR-NK, and TCR-T adoptive cell therapies. The ability of ACROBiosystems’ GMP-grade recombinant human IL-15 protein to pass PMDA certification is attributed to its comprehensive GMP production system, design without animal-derived components, and complete functional validation data. This product can specifically activate downstream JAK-STAT and PI3K-AKT signaling pathways in immune cells, significantly enhancing the cytotoxic activity and in vivo persistence of T cells and natural killer cells, effectively improving anti-tumor immune memory and reducing cell exhaustion. It can also efficiently induce the expansion and enrichment of high-quality cell subpopulations, such as stem cell-like memory T cells (Tscm) and long-lived memory NK cells. From production processes and quality control to functional validation, ACROBiosystems has established a complete regulatory support documentation package, including material compliance evidence, virus testing validation, and stability study data, providing solid support for developers in meeting the application requirements of regulatory agencies like the PMDA.

This certification provides further support for ACROBiosystems to better serve its customers and accelerate the drug development and approval process. On the business front, after receiving the official PMDA confirmation, developers of cell therapies using this IL-15 protein can directly reference this confirmation when applying in Japan, greatly simplifying the evaluation process concerning raw materials and shortening the timeline from research and development to clinical trials. By securing this confirmation from PMDA — a globally respected authority, alongside the FDA and EMA — ACROBiosystems demonstrates its commitment to meeting the highest standards of quality required for biopharmaceutical development. This certification fully verifies that ACROBiosystems’ GMP-grade raw materials meet international advanced standards for quality management systems and application registration documents, thus supporting the accelerated drug application and approval process for cell therapy developers in Japan.

In addition to Japan, ACROBiosystems also possesses complete regulatory support capabilities in major global markets: all of its GMP products undergo DMF filing with the FDA in the United States; in China and Europe, where official agencies have yet to open pathways for GMP raw material filings, the company can still provide comprehensive RSF (Regulatory Support File) documentation to assist customers in their drug applications and approvals worldwide. As of April 2026, the company has assisted nearly 30 clients in China, the United States, and South Korea with multiple applications to CDE, FDA, and KFDA, accumulating rich experience in applications.

Establishing a stringent quality management system to ensure the effective guarantee of product and service quality is a strategic decision for ACROBiosystems Group. Since its establishment, the group has continuously improved its quality management system, aiming to accelerate the development and approval process of biopharmaceuticals. ACROBiosystems Group first obtained ISO 9001 certification in 2016, followed by ISO 13485 certification in 2018, and established a GMP quality management system in 2021. In 2024, its GMP production site in Suzhou received dual ISO 9001 and GMP certification. In 2025, both the Beijing and Suzhou sites received authoritative certification from the RX360 International Pharmaceutical Supply Chain Alliance. The company has an experienced professional quality management team familiar with the biopharmaceutical regulations of different countries and regions, closely follows industry trends, and can rapidly establish or improve quality management systems according to different product types, customer applications, and changing regulatory requirements, thereby facilitating appropriate product development and production to meet diverse customer needs while aligning with regulatory requirements and market conditions. ACROBiosystems is committed to providing partners with the highest quality products and the most comprehensive regulatory support documentation, continuously safeguarding the biopharmaceutical approval process.

About ACROBiosystems Group：

ACROBiosystems Group, founded in 2010 and listed in 2021, is a biotechnology company aimed at being a cornerstone of the global biopharmaceutical and healthcare industries by providing innovative products and business models. The company spans across the globe and maintains offices, R&D centers, and production bases in more than 15 different cities within the United States, Switzerland, the United Kingdom and Germany. ACROBiosystems Group has established numerous long-term and stable partnerships with the world’s top pharmaceutical enterprises, including Pfizer, Novartis, and Johnson & Johnson, and numerous well-known academic institutes. The company comprises several subsidiaries such as ACROBiosystems, bioSeedin, Condense Capital, and ACRODiagnostics.

ACROBiosystems’ brands include Resilient Supply, CytoPak, SAFENSURE, FLAG, Star Staining, Aneuro, ComboX, GENPower and many others. Its main products and services are recombinant proteins, kits, antibodies, scientific services, and other related products. ACROBiosystems employs a strict quality control system for its products that are used in biopharmaceutical research and development, production, and clinical application. This includes targeted discovery and validation, candidate drug screening/optimization, CMC development and pilot production, preclinical research, clinical trials, commercial production, and clinical application of companion diagnostics.

Through the continuous development of new technologies and products, ACROBiosystems Group creates value for the global pharmaceutical industry and actively empowers our partners. The company is dedicated to accelerating the drug development process, including targeted therapies, immunotherapeutic drugs, and their clinical applications, and contributes to global health.

WASHINGTON, July 14, 2026 /PRNewswire/ — On July 14, 2026, the U.S. Fish and Wildlife Service (“USFWS”) for the second time declined to accept a petition filed by People for the Ethical Treatment of Animals (“PETA”) and other activist groups to list long-tailed macaque (“LTM”) monkeys (Macaca fascicularis) under the U.S. Endangered Species Act (“ESA”).

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The U.S. Fish and Wildlife Service determined that PETA’s petition¹ to list LTM monkeys under the ESA does not present substantial scientific information warranting further review. This is the second time USFWS has rejected a petition from PETA to list this nonhuman primate species in the last three years².

“The National Association for Biomedical Research commends USFWS for conducting a thorough, science-based review of the petition submitted by activist groups and for its determination that LTM monkeys do not warrant listing under the ESA,” said Matthew R. Bailey, president, National Association for Biomedical Research (NABR).

“It is clear from the record that activist groups like PETA have attempted to weaponize the ESA and other environmental processes to block or hinder medical research in the United States and around the world. Doing so not only jeopardizes human health and safety, but it undermines the value of these environmental processes when they are used as tools to further political agendas,” added Mr. Bailey.

“NABR will continue to engage in these processes to protect medical research in the U.S. and around the world to ensure decisions regarding species protection are based on the best available scientific and commercial data.”

LTM monkeys are used extensively throughout the world in biomedical research given their close approximation to human beings. The importation and use of this nonhuman primate species in biomedical research is strictly regulated by international bodies and U.S. federal agencies.

Medical research using LTM monkeys has been crucial for advances in regenerative medicine³, immunology⁴, cancer⁵, vaccine development⁶, and pharmacology⁷. The National Institutes of Health (NIH) recently published a review confirming the importance of LTM monkeys in conducting biomedical research⁸.

“Due to their physiological and biological similarities with humans, LTM monkeys are a crucial resource for pre-clinical biomedical research. They contribute to the development of therapies before the human clinical trial stage of development,” said Mr. Bailey. “LTM monkeys have been instrumental in the development, and in safety and efficacy assessment, of many of today’s medicines and treatments. They continue to be invaluable for biomedical advancements.”

About the National Association for Biomedical Research
Founded in 1979, the National Association for Biomedical Research (NABR) is the only 501(c)(6) nonprofit association dedicated to sound public policy for the humane use of animals in biomedical research, education, and testing. Members include more than 280 universities, medical and veterinary schools, teaching hospitals, pharmaceutical and biotechnology companies, patient groups, and academic and professional societies who rely on humane and responsible animal research to advance global human and animal health. Learn more about us at www.nabr.org.

¹ https://www.peta.org/media/news-releases/peta-primate-experts-file-legal-petitions-to-new-administration-to-protect-monkeys-not-profits/
² https://www.nabr.org/about-nabr/news/fish-wildlife-service-long-tailed-macaques-esa
³ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8848615/#:~:text=Non%2Dhuman%20primates%20play%20a,organs%20affected%20by%20degenerative%20diseases. regenerative medicine
⁴ https://www.nature.com/articles/s41577-018-0005-7. immunology
⁵ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9808758/#:~:text=Furthermore%2C%20NHP%20naturally%20develop%20cancers,and%20patients%20with%20human%20cancer. cancer therapies
⁶ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8402317/. vaccine development
⁷ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5886327/. pharmacology
⁸ https://orip.nih.gov/about-orip/research-highlights/nonhuman-primate-evaluation-and-analysis-final-report 

Eva Maciejewski
emaciejewski@nabr.org
(202) 967-8305

SILICON VALLEY, Calif., July 14, 2026 /PRNewswire/ — M Social Hotel Sunnyvale, the new lifestyle hotel owned by Millennium Hotels and Resorts, set to debut in the heart of Silicon Valley in Fall 2026, is pleased to announce the appointments of Jakub Skyvara as General Manager and Tina Walters as Director of Sales & Marketing. Bringing decades of hospitality leadership experience across luxury hotels, lifestyle brands, and leading Silicon Valley properties, the duo will help lead the launch and strategic positioning of the highly anticipated hotel.

“We are delighted to welcome Jakub and Tina to our growing M Social Hotel Sunnyvale family,” said Shah Adil, Senior Vice President, Operations, Asset Management & Development- America’s. “As M Social continues to expand its presence as a lifestyle brand, Sunnyvale represents an exciting growth opportunity in one of the country’s most dynamic business and innovation markets. Jakub and Tina’s combined expertise across hotel operations, luxury hospitality, sales, and market strategy will be instrumental in driving the hotel’s successful opening, strengthening operational performance, and establishing M Social Hotel Sunnyvale as a vibrant new destination for both travelers and the local community.”

As General Manager, Jakub Skyvara will oversee all hotel operations and lead the launch of M Social Hotel Sunnyvale, bringing more than two decades of global hospitality experience spanning North America, Europe, and Asia. Most recently, Skyvara served as General Manager of The Lodge at Torrey Pines, where he upheld AAA Five Diamond standards while advancing guest satisfaction, service culture, and overall asset performance. His career also includes leadership roles with globally recognized hospitality brands including Mandarin Oriental, Four Seasons Hotels and Resorts, and Viceroy Hotels & Resorts, as well as Executive Assistant Manager at The Resort at Pelican Hill. At M Social Hotel Sunnyvale, Skyvara will focus on creating a hospitality experience that reflects the creativity, energy, and innovation synonymous with Silicon Valley.

“M Social Hotel Sunnyvale has the opportunity to become a true social hub for Silicon Valley,” said Jakub Skyvara. “Our focus will be on creating an energetic, well-executed hospitality experience that reflects the creativity of the destination and the spirit of the M Social brand.”

Joining as Director of Sales & Marketing, Tina Walters brings more than 30 years of experience in hospitality, travel, and account management, alongside deep-rooted connections within the Silicon Valley business community. A Silicon Valley native, Walters has held leadership positions across a number of prominent hospitality brands including Hyatt, Marriott, Hilton, Kimpton, Starwood, Hyatt Centric Santa Clara Silicon Valley, and Hyatt Place Santa Barbara. She also previously led sales and marketing efforts for The Ameswell Hotel in Mountain View.

M Social Hotel Sunnyvale will feature 263 contemporary guestrooms, globally inspired dining concepts, and approximately 24,000 square feet of flexible meeting and event space, including what will be the largest ballroom in Silicon Valley. Located near Highway 101 and San Jose Mineta International Airport, the hotel is designed to serve as a vibrant social hub for both travelers and the local community.

For more information about M Social Hotel Sunnyvale, please call 303.779.2002 or visit www.msocial.com/en/sunnyvale.

About M Social Hotel Sunnyvale
M Social Hotel Sunnyvale is Silicon Valley’s premier lifestyle destination for business and leisure travelers alike. Located in the heart of one of the world’s leading centers of innovation and situated near Highway 101 and San Jose Mineta International Airport, M Social Sunnyvale offers guests an immersive experience where contemporary hospitality meets the energy, creativity, and entrepreneurial spirit of the Bay Area. Featuring 263 rooms, signature food and beverage concepts Beast and Butterflies, and approximately 24,000 square feet of flexible meeting and event space anchored by a 6,600-square-foot ballroom, the largest hotel ballroom in Silicon Valley, M Social Sunnyvale blends the best of both worlds, seamless connectivity to major corporate campuses and key Bay Area destinations with vibrant spaces designed for social connection, business gatherings, and modern travel, positioning the hotel as a vibrant new hub in Silicon Valley and providing the ultimate Silicon Valley escape for the modern-day traveler. For more information about M Social Hotel Sunnyvale, please visit www.msocial.com/en/sunnyvale.

About Millennium Hotels and Resorts
Millennium Hotels and Resorts (MHR) is a dynamic, global hospitality group with properties spanning four continents and 80 destinations. With a reputation for excellence, MHR owns, manages, and operates over 150 properties worldwide including in New York, Los Angeles, London, Paris, Dubai, Abu Dhabi, Auckland, Beijing, and Singapore. Its diverse portfolio spans brands including The Biltmore, Grand Millennium, Millennium, M Social, Studio M, M Hotel, Copthorne, and Kingsgate—offering the perfect address for business and leisure travellers who are looking for hospitality experiences that go above and beyond. MHR is a Hong Leong Group subsidiary of Singapore-listed global real estate company City Developments Limited. For more information, visit www.millenniumhotels.com.