BEIJING: Could Chinese pharmaceutical companies help mass-produce certain drugs to strengthen the global fight against Covid-19 that is already in its third year, and thus show that their products can be game-changers? Such a question won’t be dismissed in a jiffy anymore, industry insiders say.

       Given the contagious Omicron variants, what might prove effective are mass-produced, low-cost small-molecule oral antiviral drugs that can be stored easily and accessed widely by outpatients, they said.

       To that end, Chinese pharmaceutical companies have been making increasing contributions.

       For instance, Shanghai Junshi Biosciences Co Ltd, a Chinese innovation-driven biopharmaceutical company, announced in March a global phase-three trial on the efficacy and safety of VV116, a treatment candidate for moderate to severe Covid-19.

       The investigational drug is jointly developed by Junshi Biosciences and several other domestic entities, including Vigonvita Life Sciences Co Ltd and three institutes of the Chinese Academy of Sciences.

       A phase-two clinical trial of VV116 completed in subjects with moderate to severe Covid-19 in Uzbekistan last year showed two different doses of VV116 had favourable safety and efficacy in the treatment of both moderate and severe Covid-19 patients in comparison with standard therapy.

       Based on the positive results, VV116 has been approved for the treatment of moderate to severe Covid-19 patients in Uzbekistan in late 2021. Another global phase two and three clinical study of VV116 is ongoing for the early treatment of mild to moderate Covid-19 patients.

       That is just one example of how biotech and pharmaceutical companies in China, inspired by the national agenda of innovation-driven development, have been ramping up innovation efforts to enhance their research and development activities.

       Some of them have been able to conduct world-class research and development (R&D) on cutting-edge treatments, especially in the biotech sector.

       Franck Le Deu, a senior partner with McKinsey & Company, wrote recently on his LinkedIn blog that China has emerged as an important actor in the global biopharma ecosystem, adding a potent additional source of global biopharma innovation and disruption.

       Chinese biopharma has very good access to the necessary ingredients for innovation, he wrote in the blog.

       China’s 2022 Government Work Report said the nation will do more to promote business startups and innovation initiatives and improve the service capacity of entrepreneurship and innovation platforms.

       The country needs to promote scientific and technological innovation, to upgrade industries, eliminate the bottlenecks in the supply chain and realise high-quality development through innovation, it said.

       Analysts and business leaders said the nation’s unwavering efforts to encourage and support innovation have paid off after the state council, China’s cabinet, released a document on reforming the review and approval system for drugs and medical devices in 2015.

       The emphasis on innovation in China will give rise to a new wave of achievements in the industry, they said.

       Wei Dong, chief executive officer of EdiGene, a Beijing-based biotech company developing genome-editing technologies, said the biopharma and pharmaceutical industry in China is growing rapidly.

       Since 2015, the industry has been elevating its focus from generics to innovation and developing from “me-too” and “me-better” to “first-in-class”, grasping the latest trends like the cell and gene therapy, a global hot spot in the industry, he said.

       On the one hand, Chinese biotech and biopharma firms focusing on small-molecule therapeutics and macromolecular therapeutics are further improving their R&D capabilities and have first-in-class potentials in their pipelines, especially among early-stage programs.

       On the other hand, in the field of cell and gene therapy, companies like EdiGene have accumulated enough expertise and experience to translate innovative technologies into transformative therapies.

       Jiangsu Recbio Technology Co Ltd, an innovative vaccine company founded in 2012 in Taizhou, Jiangsu province, is among the very few enterprises in the world that can develop novel adjuvants to US Food and Drug Administration (USFDA) standards. An adjuvant is an ingredient used in some vaccines that helps create a stronger immune response.

       Recbio’s rich vaccine portfolio includes vaccine candidates for HPV (human papillomavirus), shingles, influenza and adults’ tuberculosis. Now, it also has a novel adjuvant recombinant Covid-19 vaccine undergoing phase two and three clinical trials.

       Clinical studies have shown the vaccine candidate’s immunogenicity – it is a term that denotes a substance’s ability to produce an immune response – is at least comparable to Moderna/Pfizer’s mRNA vaccine, and it can induce high levels of neutralising antibodies against the Delta, Omicron and other Covid-19 variants, said Liu Yong, founder and chairman of Recbio.

       Another Covid-19 vaccine Recbio is developing is the world’s first lyophilised mRNA vaccine, which can be stored and transported in conventional cold-chain conditions. If this vaccine receives regulatory approvals, it is expected to greatly improve the accessibility of mRNA vaccines.

       The vaccine candidate has induced a high-level neutralisation response against both the wild-type and the Omicron strains in mice experiments.

       “Thanks to supportive government policies, the R&D, production and commercialisation of the domestic pharmaceutical industry have been undergoing remarkable positive evolution,” Liu said.

       “Policy measures that attract high-end talent from overseas, encourage high-tech enterprises to grow and increase financing channels for enterprises, have all provided strong support for companies in the sector, apart from reinforcing the healthy economic fundamentals and growing demand in the health market,” he said.

       According to Le Deu with McKinsey, the Chinese biopharmaceutical industry’s innovation focus has broadened significantly into all major modalities and disease areas.

       For nine out of 10 modalities and for nine out of 13 disease areas, Chinese companies are now leading multinational companies in innovation in China’s domestic market. — China Daily/ANN