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Why China Still Doesn’t Have an mRNA Shot (Caixin)
2022-07-14
As the fast-evolving coronavirus tests scientists’ capacity to develop more-effective vaccines, drugmakers in China are scrambling to catch up with the most advanced technology for producing more powerful shots to better protect the world’s largest population. Since the pandemic started, China has approved seven home-grown Covid-19 vaccines using four proven technologies to back the country’s vaccination campaign, the world’s largest. But shots based on the new mRNA technology that have been widely used elsewhere are still not available in China. MRNA vaccines, led by products developed by Pfizer-BioNTech and Moderna, have outperformed most other shots in efficacy rates against Covid-19. “Although the Ministry of Science and Technology in 2020 announced five technology routes (for Covid vaccine development), there hasn’t been any mRNA shot approved,” said Shen Haifa, chief scientist of Stemirna Therapeutics Co. Ltd., one of the Chinese companies engaged in mRNA vaccine development. China’s domestic development of mRNA-based Covid vaccines has lagged behind expectations, underscoring technology shortfalls, experts said. “There are only two companies in the world that have mastered the full set of technologies for the industrialization of mRNA vaccines, and China is still in the stage of catching up,” said Zhang Xiaofan, chief operating officer of Everest Medicines. Everest is working on clinical trials and commercialization in China of an mRNA shot developed by Canadian biotech company Providence Therapeutics. Compared with global industry leaders such as Pfizer Inc. and Moderna Inc., Chinese mRNA vaccine developers are less experienced. Stemirna, one of the earliest pioneers in the country, was founded only six years ago. “All companies in the sector have technical defects,” a Stemirna employee said. “China is still lagging behind,” While domestic research struggles to catch up, efforts to import foreign-developed shots and obtain technology transfers have fallen behind schedule. One of the key players in China’s mRNA vaccine development is Shanghai Fosun Pharmaceutical Co. Ltd., which obtained the exclusive rights to market BioNTech’s mRNA-based Covid-19 vaccines in greater China even before Pfizer’s investment in BioNTech SE. But progress for Fosun to deliver the BioNTech shots to China has been slow. The latest good news was in July 2021, when Fosun CEO Wu Yifang said the vaccine was close to completing reviews by China’s drug regulators. Fosun has provided no update since. A person with knowledge of the matter told Caixin in April that BioNTech was in discussions with Chinese regulators over the import registration of its mRNA shot. BioNTech was open to pushing forward technology transfer to China, and the Chinese regulators were fully aware, the source said. BioNTech and Fosun have been working on the matter, but there are obstacles due to local partners’ technical capacity and quality control capability, the person said.
Although mRNA technology was invented long ago, it has only been successfully applied to vaccines in the past two years. The Chinese pharmaceutical industry has a shorter history compared with that of rivals in many other countries. A number of Chinese biotech companies have joined the race, attracting billions of dollars of investment. But none has yet to win approval to start production. One of the frontrunners is a shot jointly developed by Walvax Biotechnology Co. Ltd. and Abogen Biosciences Co. Ltd. Known as AWcorna, the vaccine candidate is in phase 3 clinical trials in several countries overseas while under study as a booster shot in China. The companies have yet to announce completion of the phase 3 trials or any data from phase 2 trials, falling behind schedule. Phase 2 trials generally gauge a treatment’s proper dosage, and phase 3 tests assess its safety and effectiveness in a broad range of people. Phase 1 data released in January sparked concerns over AWcorna’s safety due to a high rate of adverse reactions, including fever. Phase 1 trials usually involve a relatively small number of subjects and are intended to determine a treatment’s safety in humans. In late May, the latest data on using AWcorna as a booster shot also indicated a higher rate of fever compared with the inactivated virus vaccines that have been widely used in China. A candidate developed by Stemirna won approval to begin phase 1 clinical trials in January 2021. In June that year, Stemirna Chairman Li Hangwen said the vaccine would start the next phase of tests very soon. But two months later, Stemirna’s partner in developing the vaccine, Tibet Pharmaceutical Inc., announced a surprise termination of the partnership, a major blow to the project. No further information about the shot has been disclosed since. While research progress remains slow, Chinese vaccine-makers may face greater challenges in mass production due to the complicated chemical components and procedures required by mRNA vaccines, experts said. Lin Jinzhong, cofounder of RNACure and a research fellow at the School of Life Sciences Fudan University, told Caixin that mRNA vaccines need more than 300 ingredients, and some key materials are not adequately supplied in China. Some equipment needed for mass production of mRNA vaccines is also absent in China, said Stemirna’s Shen. He said his company invested heavily with equipment manufacturers in developing such devices. Another major challenge lies in access to a basic patent in mRNA vaccine development. Among mRNA vaccines currently on the market, the mainstream delivery system is lipid nanoparticle (LNP). The patent for this system belongs to a few Western companies and institutions such as Arbutus Biopharma Corp. The technology has been used by Moderna and BioNTech to develop their Covid-19 vaccines. While BioNTech indirectly obtained the right to use the technology, Moderna lost a lawsuit regarding the patent in late 2021 and faces heavy penalties. Chinese vaccine-makers need to develop an alternative if they don’t use the LNP system. Stemirna is studying a new technology known as the Lipopolyplex (LPP) delivery system, which is still in an early stage of development. China lacks basic technology and systematic research in the mRNA vaccine field, a senior industry insider said. More efforts should be made to accumulate experience and build systems to beat the formation of patent barriers by overseas companies, the person said.
Regulatory authorities are also speeding up to catch up with the development of mRNA vaccines. “The approval of a new drug involves the understanding of the drug as well as a slew of criteria and methodologies,” Shen said. Without any precedent in mRNA vaccine approval, companies and authorities must strengthen communication to improve the approval process, he said. In an internal meeting in June, an executive of Fosun said regulatory authorities still held a wait-and-see attitude toward the mRNA vaccine technology. But the executive said the company is confident about the BioNTech shot and will continue working with regulators for approval. Despite the many challenges, the race for China’s homegrown mRNA shots is getting more crowded. In April, two more mRNA candidates developed by CanSino Biologics Inc. and CSPC Pharmaceutical Group Ltd. separately were approved for clinical trials in China, with more players expected to join the race.
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China to ease residency restrictions in urban areas (Xinhua)
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Alleged sexual assault incident at Peking University draws online debate, police investigation underway (China Daily)
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Former Chinese police boss Fu Zhenghua to face court on corruption charges (SCMP)
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