What is the solution to the predicament of Chinese bioplasics companies?This heavy internationalized conference is full of dry goods

Qilu.com · Lightning News August 19th. On August 18, 2022 International Conferences of Pharmaceutical Innovation and Development were held in Yantai. Big coffee published true insights around domestic new drugs and shared valuable experience.

The meeting was divided into two parts: theme report and the round table forum, which was chaired by Dr. Fu Daodian, president of Rongchang Bio, and Dr. Ruyi, Chief Medical Officer. Pei Gang, an academician of the Chinese Academy of Sciences, former president of Tongji University, He Ruyi, chief medical officer of Rongchang Biology, Zhang Dan, an academician of the Russian Academy of Engineering, the co -founder and chief strategic officer of Kunyu Medicine, and Ling Hong, Vice President of Junshi Bio, Wei, Xie Hongyan, vice president of Kobit attended the meeting and delivered a keynote speech.

Pei Gang, an academician of the Chinese Academy of Sciences and the former principal of Tongji University, pointed out in the opening speech that people's health and biomedicine are the cause of all humanity. Therefore, internationalization is not only necessary, but also vital. In contrast, biomedicine, talent and capital, and scientific research cooperation should not be limited to a certain country, but a global market.

Internationalization is the goal and the method

The reform of the pharmaceutical review and approval system has been in the past 7 years. The Chinese pharmaceutical industry has completed the transformation of innovation from less to more, and its strength from small to large. Next, the proposition to the entire pharmaceutical industry is from large to strong, from local to global, how can the international dilemma break? Dr. He Ruyi, the chief medical officer of Rongchang Bio, brought a speech on internationalization strategies and risk control from the perspective of clinical and registration.

"Whether the internationalization path can be connected is not only a verification of innovation capabilities, but also the only way to embrace the value of the international market." Dr. Ruyi took the Rongchang creature as an example, explaining that the License-in bought well, only to buy well, only It can explain that the vision is good, the funds are strong, and the team's execution is strong. Only the License-out sells well can the bottom-level innovation ability be recognized by others. In August last year, Rongchang Bio and internationally renowned Biopharmaceutical Company SeaGen reached a global exclusive license agreement to develop and commercialize Vidicu Mipido. The milestone payment of the dollar, plus more than ten percent gradient sales commission. This License OUT authorization set a new record for domestic innovative drugs at that time. He Bo pointed out that there are many out -of -sea projects represented by emerging Biotech, and the transaction amount is quite high. The projects are mostly concentrated in the field of tumors.

The new medicine is self -going to sea, and the challenge is mainly clinical. "Different clinical trial design determines the success or failure of a clinical trial, and the success or failure of a clinical trial can determine the life and death of a company." Dr. He Ruyi, who had worked in the FDA in the United States, reminded the international layout of attention through rich case demonstrations to demo For example, to understand the requirements of local state supervision, strengthen communication with regulatory agencies, plan internationalization as soon as possible, do a good job of differentiated clinical trial design, overseas clinical trials to respect the rules of new drug research and development, avoid irritability and other progress. For example, Rongchang Bio has fully excavated its own advantages. Please ask Vidici to obtain the FDA "breakthrough therapy" for successfully obtained the recognition of the FDA "breakthrough therapy". "This shows that even the medicines with the same target, clinical trial data come from China, and can be approved by FDA according to the advantages of clinical value."

He Ruyi said that the future is beautiful and bright. In the next 10 or longer, Chinese pharmaceutical innovation will usher in the next highlight. However, success is not inevitable. There is no shortcut in innovation. Everyone needs to work together to get out of an internationalization road that is in line with their own characteristics.

In line with international, cover the full chain of the industry

According to statistics, the global biopharmaceutical market space will increase from US $ 286 billion in 2019 to US $ 768 billion in 2030, and my country's biopharmaceutical market space will increase from 312 billion yuan in 2019 to 1303 billion yuan in 2030. Chinese pharmaceutical companies are welcoming the era of comprehensive "going to sea". However, internationalization is a comprehensive concept. It not only has R & D, clinical, sales and other links, but also involves regulations, policies, supply chains and other links.

Zhang Dan, a co -founder and chief strategic officer of the Russian Academy of Engineering, Zhang Dan, co -founder and chief strategist at the Russian Academy of Engineering, reviewed the history of GCP in detail, compared the differences in multiple versions, and explored the strategy of entering the international market in the new situation. It is pointed out that China's quality standards are in line with international standards, and the key to mutual ICH data can accelerate the speed of Chinese innovative drugs entering the European and American markets.

Nanjing Vizhiko Biotechnology Co., Ltd. CSO Linghong discussed the internationalization path from the development strategy of antibody drugs and the exploration of new target exploration. He said that tumor immunotherapy and combined medication brought revolutionary breakthroughs and directions. However, the reaction rate is urgent to break through. In terms of setting up and pipeline layout, it is necessary to take the priority of clinical transformation and benefits in the field of unsatisfactory fields, and lead academic -driven research and development based on disease biology, while technical platforms and transformation research are key support.

With the internationalization of pharmaceutical companies, how to solve pharmaceutical consumables card neck technology and maintain the stability of the supply chain? Xun Hongyan, vice president of Hangzhou Kobit Technology Co., Ltd., said that the internationalization of domestic new drugs requires products of domestic suppliers to reach the same level as international companies. The main challenges include technical challenges, product batch stability challenges, and challenges of documents that meet regulations and challenges of supply chain. Real gold is not afraid of fire, crack the problem of "going to sea"

Why do local pharmaceutical companies go to sea? Chen Wei, vice president of Junshi Bio, is recognized as the main reason: for the "double inner rolls" of prices and products, the research and development capabilities of local pharmaceutical companies under the "China and the United States Double News" are becoming more mature, and it is better to seek better quality "fertile soil". The land breeding innovation "seedlings" and the realization of investors' commitments. It turns out that product competitiveness, clinical development capabilities, overseas application registration capabilities, commercialization capabilities, and global industrial chain capabilities all determine how far the road to Chinese biomedical companies can go.

In the roundtable forum, Cheng Long, vice president of Rongchang Bio, and Huang Kaisheng, the chief quality officer, conducted in -depth exchanges around the issue of "opportunities and challenges for Chinese pharmaceutical companies to go to sea".

Based on the domestic and foreign registered experience at home and abroad, Dr. Cheng Long believes that whether it is CDE or FDA, the main purpose of supervision is to protect and promote public health, that is, the balance of drug effectiveness and safety. Really solve the actual clinical needs, there are differentiated innovations in the selection of indications and the breakthroughs of the target, and the clinical data is excellent, and the regulatory authorities will encourage such research and development. For example, after the Rongchang creature submits the data of the rare disease to the FDA, they are very recognized, and they even recommend the company to report to breakthrough therapy. The so -called "Diamond Diamond is not afraid of picking porcelain", as long as it can meet the clinical needs that have not been met, you will be confident.

Dr. Huang Kisheng took Thai Sip as an example to explain the "secrets" of China's innovative medicine to the world. He said that he needs to be hard to hit the iron, and we must have a good product that can stand in the world. The international layout of the supply chain is to have special regulatory requirements in each place. In addition, regulatory agencies and enterprises need to work together. Top innovation drugs should become a talent training base for talents, and inheritance from generation to generation, so as to truly push China's innovative drugs to the international market.

Everyone believes that innovation medicine must belong to the world, and the ability of Chinese companies to go to sea depends on its own strength. Chinese innovation pharmaceutical companies that have just appeared on the global stage have just begun.

Lightning reporter Liu Yuliang report

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