Three new Chinese vaccine companies seek entry into Pakistan

Three new Chinese companies, known to develop Covid-19 vaccines, are poised to enter in Pakistan’s market amid a spike in positivity rate predominantly bedeviled by delta variant.

They have submitted their formal applications to launch human trials (phase III clinical trials) to attain eligibility for registration with Drug Regulatory Authority Pakistan (DRAP). After the last stage trails, if sanctioned, Chinese companies will be qualified for emergency use authentication.

Besides three new aspirants whose cases are pending approval, Chinese company CanSino Biologics Inc, started last-stage trials on September 22, 2020, in Pakistan. It is a single-shot vaccine. Now Anhui Zhifei Longcom Biologic Pharmacy Co. Ltd and the Institute of Microbiology of the Chinese Academy of Sciences are in the process to complete human trials of its ZF2001 vaccine. It is a three-shot vaccine.

University of Health Sciences (UHS) focal person Dr. Shehnoor Azhar told Gwadar Pro that all the Chinese companies and others aspiring to seek authorization to carry out human trials of their vaccines have to follow newly-established ethics protocols regarding trial participants.

Among three new Covid-19 vaccine candidates, Walvax Biotechnology Co., Ltd. is a China-based company principally engaged in the research, development, production and distribution of vaccines, monoclonal antibodies, and blood products. It produces ARCoV, also dubbed as Walvax, which is an mRNA COVID-19 vaccine. It is developed by Walvax Biotechnology, Suzhou Abogen Biosciences, and the PLA Academy of Military Science. In May 2021, Phase III trials started in Mexico with 6,000 people. In July 2021, Phase III trials started in Yunnan and Guangxi in China with 2,000 people. In July 2021, Phase III trials are awaiting approval by Malaysia, Colombia, Indonesia, Pakistan, and Turkey.

Livzon Pharmaceutical Group is the second Chinese company seeking official permission for human trials. It is specialized in the development and production of active pharmaceutical ingredients (APIs), biological drugs, diagnostic reagents, and other products.

Livzon Group is headquartered (Livzon Industrial Park) in Biomedical Industrial Park in Jinwan District, Zhuhai City, Guangdong Province. In April 2021, Searle (Pakistan Pharmaceutical Company) signed an agreement with a Chinese pharmaceutical group to manufacture the coronavirus vaccine in Pakistan. The Searle Company has concluded an exclusive licensing and supply agreement with Livzon Mapharm Inc. for the recombinant novel coronavirus vaccine (V-01). The licensing agreement also covers the manufacturing transition of (V-01) in Pakistan. Livzon Pharmaceutical Group was founded in 1985, listed on Hong Kong and Shenzhen stock exchanges.

Another company is named Shenzhen Kangtai Biological Products Co., Ltd. It is a listed enterprise integrating research, development, production and sales of biological products. Headquartered in Shenzhen, the company has R&D centers and industrial bases in Shenzhen and Beijing. It is one of the major hepatitis B vaccine manufacturers in China. After the outbreak of COVID-19 in early 2020, BioKangtai has started R&D and industrialization of COVID-19 vaccine. Also, it carried out the research and development of several technical routes, such as COVID-19 inactivated vaccine (Vero cell) and the adenovirus vector COVID-19 vaccine.

The COVID-19 inactivated vaccine (Vero cell) independently developed by BioKangtai has been approved for a clinical trial by the National Medical Products Administration and became the first coronavirus vaccine officially entering the clinical trial in Guangdong Province. Kangtai has also obtained the exclusive right to develop and manufacture the vaccine developed by AstraZeneca and Oxford University in Chinese mainland.

In June this year, BIOKANGTAI’s Inactivated COVID-19 Vaccine first entered Southeast Asia and launched the phase III clinical trial in Malaysia. Meanwhile, BIOKANGTAI is proactively seeking to launch clinical trials in more countries and regions in South America, Europe, etc. It has already obtained clinical approval in Ukraine and is expected to launch trials soon.

On July 30, 2021, Shenzhen Kangtai Biological Products Co., Ltd. (BIOKANGTAI) was approved by the Philippine Food and Drug Administration (PFDA) to launch the phase III clinical trial of its independently developed Inactivated COVID-19 Vaccine (Vero cells) in the local area. Earlier, BIOKANGTAI has already been approved by the Vaccine Expert Panel (VEP) of the Philippine Department of Science and Technology (DOST) on June 14, and by the Single Joint Research Ethics Board (SJREB) of the Philippine Department of Health on June 21.