Kangle Biosciences Marks Major Milestone with Trial Production Launch of Recombinant Vaccine Clinical and Industrialization Base in Kunming

On the morning of August 1, 2023, the trial production launch ceremony for Health Guard (Kunming) Biotechnology Co., Ltd.’s (“Health Guard (Kunming)”) recombinant vaccine clinical and industrialization base construction project, along with the HPV vaccine technology transfer signing ceremony, was held in the Dianzhong New Area of Kunming City, Yunnan Province. This event marked a significant milestone in the development of Health Guard’s recombinant vaccine clinical and industrialization base.

Ceremony for the Launch of Trial Production for the Recombinant Vaccine Clinical and Industrialization Base Construction Project

According to Tao Ran, Director/CEO of Beijing Health Guard Biotechnology, Inc. and Executive Director/General Manager of Health Guard (Kunming), this event marks a significant leap for Health Guard (Kunming) from vaccine R&D to commercial production. The recombinant vaccine clinical and industrialization base will be developed into an eco-industrial park integrating R&D, production, logistics, and office functions, fully compliant with the current Chinese GMP, EU GMP, and WHO-GMP standards. This facility will meet the needs for the localization of innovative vaccine R&D and industrial development, thereby supporting the high-quality development of the life and health industry ecosystem in Yunnan Province.

In the future, Health Guard will leverage its advantages as a leader in the recombinant protein vaccine industry to continue actively promoting the comprehensive deployment of HPV vaccines in both domestic and international markets, strive for greater market share, create superior economic and social benefits, and contribute to the development of the vaccine industry in the Dianzhong New Area, Kunming City, and even the entire Yunnan Province.

China Vaccine Industry AssociationIn a congratulatory letter on behalf of the association, President Feng Duojia stated that the achievement of full production capacity at Health Guard’s recombinant vaccine and industrialization base project would mark a significant milestone in the journey of innovative vaccine research and development. In the future, the China Vaccines Association will continue to support and promote the development of Health Guard’s clinical and industrialization base for recombinant vaccines, making greater contributions to safeguarding public health.

Yang Dongwei, Deputy Secretary of the Party Working Committee and Deputy Director of the Administrative Committee of Yunnan Dianzhong New Area, stated that the customized construction project for Health Guard’s recombinant vaccine clinical and industrialization base is a major initiative in the biopharmaceutical sector of Kunming City and the Dianzhong New Area. The construction and commissioning of this project will effectively accelerate the rapid development of Kunming’s biopharmaceutical industry.

At the launch ceremony, Beijing Health Guard Biotechnology, Inc. and Health Guard (Kunming) Biotechnology Co., Ltd. jointly signed an HPV vaccine technology transfer agreement.

Both Parties Jointly Sign HPV Vaccine Technology Transfer Agreement

Following the ceremony, attending leaders and guests conducted an on-site visit to the vaccine bulk production workshop, gaining in-depth insights into the company’s business scale, development direction, and achievements, and engaged in detailed discussions on product manufacturing and technological R&D.

It is reported that Health Guard (Kunming), a wholly-owned subsidiary of Beijing Health Guard Biotechnology, Inc., has invested in the construction of a recombinant vaccine clinical and industrialization base in the Yunnan Dianzhong New Area. The project covers an area of approximately 140 mu and will be implemented in two phases. Phase I involves a total investment of RMB 1.195 billion, with a building area of approximately 79,353.7 square meters, including production workshops for bulk drug substances and finished products of recombinant HPV vaccines (including trivalent and nonavalent). Phase II includes a production workshop for bulk drug substances of recombinant multivalent norovirus vaccines, an R&D expert building, and other facilities. The designed annual production capacity of the base is 10 million doses of trivalent HPV vaccine, 30 million doses of nonavalent HPV vaccine, and 5 million doses of recombinant norovirus vaccine.

At this stage, Phase I of the project has been completed and delivered for use, with trial production commencing on August 1. The company aims to complete the technology transfer for the trivalent HPV vaccine and obtain the Drug Production License in the second half of 2023; complete product process validation in the first half of 2024; and, contingent upon smooth clinical progress, submit the New Drug Application (NDA) in the second half of 2024. Furthermore, subject to successful regulatory approval, the product is expected to be launched for commercial sale (including bulk drug substance exports) in 2025.

In terms of clinical progress,Health Guard’s trivalent HPV vaccine has completed the enrollment of all 8,880 subjects and the administration of three doses in its Phase III clinical trial, and is currently conducting visits for the case monitoring phase at months 30 and 36. The Phase III clinical trial of Health Guard’s nonavalent HPV vaccine for female indications has completed the enrollment of all 12,000 subjects and the administration of three doses, and is currently conducting visits for the case monitoring phase at months 24 and 30.

It is reported that the clinical development of Health Guard’s trivalent and nonavalent HPV vaccines for female indications is progressing smoothly, approaching clinical endpoints. No vaccine-related serious adverse events have been reported to date, fully demonstrating the favorable safety and tolerability profile of the vaccines. Meanwhile, Health Guard is the first company in China to obtain clinical trial approval for the male indication of the nonavalent HPV vaccine and the first to initiate clinical trials among Chinese men, thereby filling the gap in domestic research on HPV vaccines for males. As of June 30, 2023, the Phase I clinical trial has been completed, and enrollment for the Phase III clinical trial is underway.

Through this technology transfer and pilot production, the industrialization base will establish standardized production and quality management systems.Since the formal initiation of technology transfer in February 2023, Beijing Health Guard and Kunming Health Guard have collaborated effectively, comprehensively ensuring the smooth progress of technology transfer from the perspectives of regulatory compliance, organizational management, technical aspects, and risk control. This has ensured synchronization with clinical development timelines, facilitating the early market launch of HPV vaccine products.

Leveraging years of technical expertise,Health Guard Has Established Multiple Key Technology Platforms, including a structure-based antigen design technology platform, gene engineering and protein expression technology platform, vaccine engineering technology platform, and recombinant vaccine potency evaluation technology platform, and possesses three expression systems: Escherichia coli, yeast cells, and CHO cells. Benefiting from its recombinant protein technology platform, Health Guard currently has 10 human vaccine candidates in development, including a recombinant multivalent norovirus vaccine, respiratory syncytial virus (RSV) vaccine, herpes zoster vaccine, and multivalent hand, foot, and mouth disease (HFMD) vaccine. Going forward, the company will establish a market-oriented R&D mechanism to leverage the advantages of its recombinant protein technology platform and advance the layout of its subsequent R&D pipeline.

In terms of overseas strategic development planning and business layout，Health Guard’s nine-valent HPV vaccine project in cooperation with the Republic of Indonesia is progressing steadily as planned. Furthermore, Health Guard has maintained highly effective communication with the Bill & Melinda Gates Foundation and PATH (Program for Appropriate Technology in Health) over the long term, and actively responds to the WHO’s international procurement program for HPV vaccines. These efforts aim to advance the internationalization of HPV vaccines and support the Belt and Road Initiative as well as international capacity cooperation.

In the future, Health Guard will continue to adhere to a sustainable development strategy driven by both industry and capital, strengthen technological innovation, continuously deepen its layout in frontier vaccine technologies, thoroughly address significant unmet clinical needs, and develop and produce “Chinese vaccines” tailored to the genetic heritage and physiological characteristics of the Chinese population. The company will accelerate the process of domestic substitution for major biological products, striving to create high-quality vaccines for China and for the world.