Just in:
Emirati Aid Reaches Ukraine as Food Shortages Bite // Sunshine’s Debut Features Leave Tech World Scratching Its Head // French Leaders Gather for Interfaith Iftar Dinner // German Job Market Resilience Bodes Well for Economic Recovery // 2024 Lok Sabha Elections Will Be The Costliest One Till Now In The Whole World // Samsung Partners National Heritage Board to Bring a Slice of Singapore’s Cultural Heritage to Samsung The Frame TV // Universal Language for Healthcare: General Authority Embraces Global Coding System // CABSAT 2024 Ushers in 30 Years of Media Innovation // Saudi Arabia Unveils Green Financing Tool to Achieve Net-Zero Goals // Following the Money Trail: US and UK Investigate $20 Billion in USDT Transfers Tied to Sanctioned Russian Exchange // AIA Hong Kong Wins More Than 20 Accolades at MPF Ratings MPF Awards, BENCHMARK MPF of The Year Awards and Bloomberg Businessweek Top Fund Awards // Sharpening the Focus: Sharjah Health Department Refines Evaluation Criteria for “Healthy Schools Programme” // TUMI Hosts Global Launch Event in Singapore to Unveil Women’s Asra Collection and Announce Global Ambassador, Mun Ka Young // Experience Ultimate Shopping Freedom at 4.4 Shopee Spree: Don’t Worry, Shop Shopee! // Arvind Kejriwal Was Used By BJP In 2011 Movement To Take On The Congress // Ingdan Announces 2023 Annual Results // Ajman Celebrates Conclusion of Ramadan Activities with Grand Ceremony // Melco Style Presents “SANRIO CHARACTERS STUDIO CITY CARNIVAL” – Explore a SANRIO World of Unlimited Love and Cuteness // New Nylon Constant Torque Hinge From Southco Provides Position Control In A Compact Package // Andertoons by Mark Anderson for Fri, 29 Mar 2024 //
HomeAsian News by Media-OutreachYS Biopharma Received Qualified Person Declaration for Its PIKA COVID-19 Vaccine Facility from European Union GMP

YS Biopharma Received Qualified Person Declaration for Its PIKA COVID-19 Vaccine Facility from European Union GMP

Media OutReach Logo New
SINGAPORE – Media OutReach – 25 November 2022 – YS Biopharma Co., Ltd. (“YS Biopharma” or the “Company”), a global biopharmaceutical company dedicated to discovering, developing, manufacturing and commercializing new generations of vaccines and therapeutic biologics, today announced that its manufacturing facility for PIKA recombinant COVID-19 vaccine successfully passed an audit by a European Union (“EU”) Qualified Person (“QP”) and received QP declaration of its GMP equivalence to European Union Good Manufacturing Practice (“EU GMP”). PIKA recombinant COVID-19 vaccine is currently in a multi-country, multi-center, Phase III clinical trial in Southeast Asian and Middle East countries.

The audit was based on the guidance of EU GMP and the guiding principles of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The audit covered a comprehensive and in-depth audit focused on the manufacturing quality of PIKA adjuvant and PIKA recombinantCOVID-19 vaccine in the areas of pharmaceutical substance production, packaging system, quality management system and other aspects. The declaration demonstrates that the manufacturing facilities at YS Biopharma complies with European pharmaceutical GMP and has the ability to provide high quality pharmaceutical products for clinical studies and commercialization in European and international markets.

Hashtag: #YSBiopharma

ADVERTISEMENT

The issuer is solely responsible for the content of this announcement.

About PIKA recombinant COVID-19 Vaccine

Empowered by PIKA immunomodulating technology, PIKA recombinant COVID-19 vaccine is combination of the PIKA adjuvant and the SARS-CoV-2 spike (S) subunit protein. The antigen component of this candidate vaccine is based on the recombinant SARS-CoV-2 spike protein subunit with a stable prefusion S trimeric protein structure. PIKA adjuvant isa synthetic chemical analogue of double-stranded RNA (dsRNA) acting as a TLR3 agonist, which elicits both Th1 and Th2immune responses. PIKA adjuvant is able to promote the activation and maturation of dendritic cells, upregulate theco-stimulatory molecules on dendritic cells and induce the activation and proliferation of both B and NK cells.

About YS Biopharma

YS Biopharma is a global biopharmaceutical company dedicated to discovering, developing, manufacturing and commercialising new generations of vaccines and therapeutic biologics for infectious diseases and cancer. It has developed a proprietary PIKA® immunomodulating technology platform and a series of prophylactic and therapeutic biologics targeting Rabies, Coronavirus, Hepatitis B, Shingles, and influenza. YS Biopharma operates in China, Singapore, the United States, the United Arab Emirates, and the Philippines, with over 800 employees. For more information, please visit

ADVERTISEMENT

ADVERTISEMENT
Just in:
Global Audience to Witness Thrill of Dubai World Cup // Arvind Kejriwal Was Used By BJP In 2011 Movement To Take On The Congress // Ajman Celebrates Conclusion of Ramadan Activities with Grand Ceremony // Experience Ultimate Shopping Freedom at 4.4 Shopee Spree: Don’t Worry, Shop Shopee! // Hope for Respite as UAE Endorses UN Plea for Gaza Truce // CABSAT 2024 Ushers in 30 Years of Media Innovation // US reiterates concern over Kejriwal arrest, Cong accounts // First-Ever Fortune Innovation Forum Draws Top Global Leaders to Hong Kong, Promoting Agendas On Collective Cross-Sector Advancement // Andertoons by Mark Anderson for Fri, 29 Mar 2024 // TUMI Hosts Global Launch Event in Singapore to Unveil Women’s Asra Collection and Announce Global Ambassador, Mun Ka Young // French Leaders Gather for Interfaith Iftar Dinner // Ingdan Announces 2023 Annual Results // New Nylon Constant Torque Hinge From Southco Provides Position Control In A Compact Package // German Job Market Resilience Bodes Well for Economic Recovery // Andertoons by Mark Anderson for Thu, 28 Mar 2024 // AIA Hong Kong Wins More Than 20 Accolades at MPF Ratings MPF Awards, BENCHMARK MPF of The Year Awards and Bloomberg Businessweek Top Fund Awards // Infineon and HD Korea Shipbuilding & Offshore Engineering jointly develop ship electrification technology // U.S. Compliance Takes Center Stage at OKX Following Industry Jitters // Sharpening the Focus: Sharjah Health Department Refines Evaluation Criteria for “Healthy Schools Programme” // 2024 Lok Sabha Elections Will Be The Costliest One Till Now In The Whole World //