China's first novel coronavirus neutralizing antibody approved for market

Survival is the first need of civilization, as liu Cixin put it in the three-Body Problem. It is the COVID-19 pandemic that is still spreading around the world that has made people realize the meaning of this saying since the beginning of the new century. Humanity, too, has proved resilient, with vaccines, drugs, quarantines and other measures to keep the virus at bay after nearly two years.

On December 9, the first novel coronavirus neutralizing antibody (Amberavizumab/romisizumab) developed by a Chinese company was successfully approved for marketing. This means that China, the world's leading country in epidemic prevention, has officially acquired its own anti-covid-19 neutralizing antibody drugs. In the face of the trend of normalizing the epidemic, we have another powerful weapon in the prevention and control of the epidemic.

Just like China's speed in the process of fighting the epidemic in the past, the development of neutralizing antibody is also amazing. It only took 20 months for the drug to be approved for market, which can be called "rocket explosion" for innovative drug research and development that usually takes 5-10 years, and China's speed shows no doubt.

The approval of the first domestically produced BLA neutralizing antibody shows China's speed

Just after the outbreak of COVID-19, As a leader in the field of infectious diseases, Tengsheng Huachuang, together with Tsinghua University and The Third People's Hospital of Shenzhen City, quickly established Tengsheng Huachuang. Subsequently, with the strong research and development capabilities of all partners, tengsheng successfully isolated and obtained non-competitive novel Coronavirus neutralizing antibodies from serum of patients in the recovery stage of COVID-19.

Subsequently, clinical trials were completed in less than six months from lead drug selection to the first dose in humans. In October 2020, activ-2 and Activ-3 were included. Subsequently, with excellent clinical performance, its clinical trial progress was rapidly advanced.

Figure 1: Recent progress of neutralizing antibodies against COVID-19

Source: Company announcement, collated by Gronhui

In just over one year, we completed the whole process from project approval to market approval, and the speed of research and development is much faster than similar products.

Ambavizumab/romizimab (Bri-196 / Bri-198) combination therapy not only has the "Chinese speed", but also is the "Chinese antibody" superior to other international products in terms of effectiveness and safety. It not only showed neutralizing activity against the main known mutated strains, but also showed a treatment window of up to 10 days, which was significantly better than the current treatment window of 3, 5 or 7 days of other drugs, and its risk reduction rate of hospitalization and death was as high as 80%, which was also in the forefront.

Due to its excellent clinical efficacy, the combination therapy was also sent to the epidemic areas as the only designated treatment drug for the treatment of COVID-19 patients. From June to November 5, 2021, Tansenbo provided a total of more than 2,300 doses of ambayzumab/romizimab (Bri-196 / Bri-198) COVID-19 neutralizing antibody, supporting 18 hospitals in 17 regions to treat patients. As of November 5, nearly 900 patients, including mild, general, severe and critical patients, have been treated with ambayzumab/romizimab (Bri-196 / Bri-198) combination therapy. The oldest patients receiving ambayzumab/romizizumab combination therapy were 92 years old.

Chart 2: Support for affected areas

Source: official website of the company, collated by Glonhui

Such excellent results, thanks to the joint efforts of Tengshengbo Pharmaceutical, Tsinghua University and Shenzhen Third People's Hospital, through the construction of a sound industry-university-research cooperation system, give full play to the advantages of all parties. Under the leadership of Professor Linqi Zhang of Tsinghua University, the team quickly completed the preliminary work, including analyzing the three-dimensional structure of the virus, locating the target of action, and clarifying the molecular mechanism of the virus.

Subsequently, The company was responsible for providing drug development expertise, antibody optimization, intellectual property protection, project management, contract R&D and Manufacturing Organization (CDMO) management, and supervision of clinical trials and drug registration. With the mature and perfect R&D system of Tengshengbo Medicine, the basic scientific research achievements will be quickly landed and commercialized.

Through the close collaboration of the three parties, the novel coronavirus neutralizing antibody (BRI-196 / Bri-198) has been successfully marketed. According to the disclosed data, the neutralizing antibody has extended the half-life of the drug to at least 60 days through genetic modification, thus it may also have an excellent performance in preventing novel coronavirus infection in the future.

In the future, through active prevention of vaccines and passive prevention of neutralizing antibodies, there will be an opportunity to effectively protect the vast majority of people, including those who are not covered by vaccines, which may help the prevention and control work after the normalization of the epidemic and bring us closer to truly defeating the epidemic.

Teng Sheng Bo Pharma enters a new stage of 2.0, ushering in the era of Bio Pharma

Behind the "China Speed" of amberavizumab/romizimab (Bri-196 / Bri-198) COVID-19 neutralizing antibody is a company with an equally impressive growth rate -- Tengshengbo Pharmaceuticals. Founded in 2017, the company has successfully commercialized its products in just four years, which is an amazing development speed for an innovative drug company.

As the company's first products began to market sales, the company has successfully entered the stage of 2.0, and as a focus on major infectious diseases and diseases of the central nervous system innovation in the field of two drug companies, the company is worth to pay close attention to the differentiation of pipeline layout, in addition to the already listed on the new crown neutralizing antibody drugs, the company also has the first possible second liver functional cure drug combination; Better and easier delivery of anti-HIV drugs; Broader spectrum of drugs against MDR/XDR Gram-negative bacilli; And medications specifically for postpartum depression.

Chart 3: Product pipeline diagram

Source: Company announcement, collated by Gronhui

Differentiated pipelines bring stronger competitiveness, and such pipeline layout also requires the company to have strong talent advantages. Founder Dr. Hong Zhi was formerly senior Vice President and head of GSK's Infectious Division and a global leader in the development of infectious drugs. Luo Yung-ching, the president, was gilead's general manager in China, where he led the development of eight drugs. In addition, the company also has a research and development team of 98 people, as well as a strong scientific advisory board, to ensure the company's strong research and innovation strength.

Based on the team's past experience in multinational pharmaceutical companies, Tengshengbo pharmaceutical has had the gene of globalization from the beginning of its establishment. In terms of globalization, tengshengbo pharmaceutical has arranged anti-HIV drugs for the European and American markets, and anti-HBV drugs for the domestic market. In the face of a global epidemic, ambavizumab/romizimab (Bri-196 / Bri-198) was developed. In the current domestic strength of innovative drug enterprises have "go to sea" pattern, Tengshengbo medicine with a series of relative advantages of the product pipeline or will usher in the future "go to sea" opportunities.

In terms of commercial layout, prior to the approval of AMberavizumab/romizizumab (Bri-196 / Bri-198) NOVEL coronavirus neutralizing antibody BLA, the company had already planned ahead of schedule to apply for registration and commercialization of the treatment with an additional $100 million. Coy Stout, formerly of Gilead, was appointed senior vice President and Head of U.S. Market access and patient advocacy. As the product was officially approved, the production and sales of neutralizing antibodies were gradually expanded, and Tengshengbo pharmaceutical changed from a biotech company to bio Pharma. The launch of COVID-19 neutralizing antibody not only confirms the company's strong innovation ability, but also reflects the company's long-term value.

summary

The rapid approval of amberavizumab/romizimab (Bri-196 / Bri-198) NOVEL coronavirus neutralizing antibody BLA once again demonstrates the "Chinese speed" of China's response to COVID-19. In fact, in the process of drug approval, a series of support measures adopted by the NATIONAL Food and Drug Administration have also effectively accelerated the listing process of new drugs, which is a reflection of the regulatory body's concept of protecting and promoting public health and a flexible system design based on protecting the interests of critically ill patients. Against the backdrop of the normalization of the COVID-19 epidemic, the COVID-19 neutralizing antibody of Tengsheng Bo medicine will bring zero breakthrough to the treatment of COVID-19 in China and benefit more patients with COVID-19.

For Tengshengbo Medicine, it is also of great significance. On the one hand, it means that the company officially has self-hematopoietic ability. In the future, the sales of this drug will provide sustainable cash flow for the company to support the subsequent development of the company. On the other hand, it also verifies the company's strong growth ability. Opportunities are always left to those who are prepared. Tengsheng Bo Medicine can achieve such results in such a short time, which is inseparable from its own strong strength.