■ Fang Sheng, Reporter, Shenzhen Special Economic Zone Daily

In recent days, Shenzhen has been experiencing relentless heat. At the inactivated COVID‑19 vaccine production base of Shenzhen Kangtai Biological Products Co., Ltd. in Nanshan District, the production lines are operating at full capacity, with all efforts focused on ramping up output.

Recently, the inactivated COVID‑19 vaccine developed by Kintgen Biotech was recommended by the National Health Commission and approved for emergency use following an expert review conducted by the National Medical Products Administration. This is also the first COVID‑19 vaccine in Guangdong Province to receive emergency use authorization, marking a significant milestone in Shenzhen’s efforts to advance COVID‑19 vaccine research and development and industrialization.

Working around the clock to advance vaccine development.

As early as February 2020, shortly after the outbreak of the COVID‑19 pandemic, Kangtai Biological began initiating vaccine research and development, and in September of the same year obtained clinical trial approval from the National Medical Products Administration.

Since the 2020 Spring Festival, all employees of Kintor Pharmaceutical in Shenzhen have actively responded to the national call to fight the epidemic. Putting aside the opportunity to reunite with their families, they remained at their posts while rigorously implementing all preventive and control measures. On the one hand, they ensured the orderly continuation of production, with no cases of infection; on the other, they swiftly launched research and development of a COVID‑19 vaccine. In the early stages, lacking a P3 laboratory, Kintor’s scientists worked tirelessly to secure one through extensive coordination, ultimately completing the initial R&D phase in a cramped 7‑square‑meter lab. From the beginning of 2020 to the present, Kintor’s senior management has lived and eaten on campus alongside all staff, forgoing even a single weekend off, working around the clock and remaining ever‑ready, all in pursuit of the swift success of vaccine development and its timely entry into production.

In April 2021, encouraging news emerged: the Phase I/II clinical trial data for Kangtai Biological’s inactivated COVID‑19 vaccine were published on the MedRxiv platform—jointly operated by Yale University, Cold Spring Harbor Laboratory, and The BMJ—and in the English-language edition of the Chinese Medical Journal. The results showed that the vaccine’s estimated protective efficacy exceeded 90%, with no Grade 3 or higher serious adverse events; moreover, the overall incidence of adverse reactions was not significantly different from that of the placebo group, demonstrating outstanding efficacy and safety.

Meanwhile, with the strong support and guidance of relevant municipal departments and institutions, the Kintor Pharmaceutical COVID‑19 inactivated vaccine production base was successfully completed as a disaster relief and emergency response project in Shenzhen.

The government’s efficient mechanisms have bought valuable time.

Miao Xiang, Executive Vice President of Kangtai Biological, told reporters that the company was founded in 1992 and possesses advanced R&D and manufacturing capabilities for bacterial vaccines, viral vaccines, recombinant protein vaccines, multivalent and combination vaccines, and conjugate vaccines. It has six marketed products and more than 30 candidates currently under development, placing it among the leading companies in China.

“From the very outset of the project’s approval process, our inactivated COVID‑19 vaccine facility has received high-level attention from the Municipal Party Committee, the Municipal Government, and relevant departments. Through streamlined mechanisms such as case-by-case deliberation and approval with missing documents, the project was also designated as a municipal disaster relief emergency initiative. This has secured invaluable time for the smooth commissioning of the vaccine production workshop.”

According to reports, following CanSino Biologics’ investment in COVID‑19 vaccine R&D, the Nanshan District Party Committee and District Government acted swiftly to identify the most effective construction strategies and implementation pathways, establishing a dedicated task force that worked on site and provided proactive support. The Municipal Development and Reform Commission guided the completion of workshop design and planning, land‑use approvals, and other formalities, and helped the company secure approval from the National Development and Reform Commission for the construction of a P3‑level production facility. Together, these efforts ensured the project was completed smoothly in just 116 days, setting a new benchmark for pandemic‑response infrastructure projects—the “Shenzhen Speed.” Meanwhile, the Municipal Science and Technology Innovation Commission promptly initiated the approval process for emergency research projects related to the pandemic, providing funding through municipal science‑and‑technology R&D programs to support inactivated‑vaccine development. It also actively sought support from the Ministry of Science and Technology and the Provincial Department of Science and Technology, coordinating with higher authorities to expedite the issuance of construction permits for the inactivated‑vaccine production facility. The Municipal Health Commission convened experts to offer technical guidance and assist with preparatory documentation, enabling the facility to obtain biosafety certification in approximately one month. The Municipal Market Supervision Administration proactively coordinated with relevant national agencies, helping the company secure clinical trial approval for its inactivated vaccine in a relatively short timeframe, while also expediting the import‑approval process for critical overseas viral strains and cell lines needed for adenovirus‑based COVID‑19 vaccine development. Finally, the Municipal Bureau of Industry and Information Technology worked diligently to implement various financial subsidy policies and facilitated connections with material‑supply vendors, thereby providing robust financial and logistical support for the city’s COVID‑19 vaccine R&D and manufacturing efforts.

In addition, the Municipal Public Security Bureau, the Municipal Planning and Natural Resources Bureau, the Ecological Environment Bureau, the Municipal Urban Management Bureau, Shenzhen Customs, and other departments and agencies have all provided robust support and assistance to Kintor Pharmaceutical within their respective areas of responsibility—covering project qualification reviews, vaccine R&D, project funding, and more—thereby ensuring the timely completion of this project.

A Phase III clinical trial is being conducted across multiple international centers.

“In 2020, affected by the pandemic, routine vaccination rates declined, leading to significant fluctuations in our profits. Nevertheless, we spared no expense and left no stone unturned, investing over RMB 1.5 billion in vaccine research and development as well as facility construction,” said Du Weimin, Chairman of Kangtai Biological.

Currently, Kangtai Biological is conducting international multi-center Phase III clinical trials in Malaysia, Colombia, Argentina, Pakistan, the Philippines, and other countries. The company is also advancing vaccine development against variant strains along two technological pathways—multivalent inactivated vaccines and mRNA vaccines—while, under the strict assurance of uncompromising quality, steadily expanding the production capacity of its existing inactivated vaccines.

Du Weimin stated: “To better address the current threat posed by globally circulating variant strains and to safeguard Shenzhen—a key port city—against imported risks, we are actively advancing the development of targeted new vaccines, striving to make an even greater contribution to our city and to the nation as we enter a new phase of epidemic prevention and control.”

The reporter further learned that Shenzhen has established a biopharmaceutical industry layout centered on the Nanshan High-Tech Industrial Park and the Pingshan National Biotechnology Industry Base, with other districts contributing to coordinated development. This has given rise to a number of leading and innovative enterprises, including Mindray Medical, BGI, and Kintor Pharmaceutical. In recent years, the city’s biopharmaceutical sector has maintained steady and rapid growth, with its overall scale continuously expanding, thereby becoming a new driver of Shenzhen’s economic growth.