A time to sow, a time to grow, and a time to reap. The same is true for the biopharmaceutical industry. With years of continuous policy and capital support, the innovation capabilities of China’s biopharmaceutical industry have absorbed nutrients for growth, and have accumulated rich experience in emerging fields such as antibodies, ADCs, PROTACs, and CGT therapies. The generational gap with overseas pharmaceutical companies has gradually been eliminated, and we have the power to compete with the world’s top pharmaceutical companies on an equal footing. This force drives the gears of the fate of innovative drugs from turning quietly to accelerating!
At present, innovative drug research and development is deeply involved in homogeneity, and going overseas has undoubtedly become a necessary option for innovative pharmaceutical companies to seize opportunities. The development of innovative drugs in China is ushering in an unprecedented explosion, and the wave of overseas expansion is coming fiercely. Not only has it successfully passed the FDA one after another, but the scale of collaboration has also reached a new high.
Going Overseas - Dual Filing Between China and the United States Has Become a Trend
As we all know, the United States is the world’s largest pharmaceutical market, and the FDA also has the most complete and strictest drug review system in the world. Obtaining FDA approval means that this drug has a high probability of successfully passing approval in more than 40 other regions around the world, basically gaining access to the global pharmaceutical market. As China joins ICH, dual filing in China and the United States is gradually becoming a new trend in the global layout and development of Chinese pharmaceutical companies. More and more companies are gradually turning their attention to going overseas, and more and more companies are carrying out dual declarations in China and the United States, starting their journey to overseas market.
According to statistics, the total number of new drugs approved by the FDA in 2023 will reach 66 (including 55 drugs and 11 vaccines and biologics), far exceeding 2022 and setting a five-year high. At the same time, the indications of approved new drugs are showing a trend of flourishing, among which rare diseases and tumors are still the key areas and have achieved remarkable results.
As one of the earliest CRO companies in China to provide a complete set of new drug clinical research applications that comply with both Chinese GLP and US GLP standards, Medicilon has the honor to participate in the preclinical research and development of Yuyao Biotech and Gluetacs Therapeutics, which accelerated theirs research and development process.
Medicilon now has a 29,000 square meter laboratory that has obtained NMPA drug GLP laboratory qualifications and complies with the GLP laboratory standards of the US FDA, Australian TGA, and EU EMEA. Medicilon has complete standard services for chemical discovery and pharmaceutical research. According to incomplete statistics, Medicilon has participated in the research and development of new drugs and generic drug projects, and a total of about 90 new drugs and generic drug projects have passed the approval of China’s NMPA and the US FDA and entered clinical trials in 2023. The Medicilon Registration Affairs Service Platform has an in-depth understanding of the registration regulations and policies of countries and regions such as China, the United States, Australia, and the European Union, as well as their technical requirements for drugs. We can provide domestic and foreign customers with drug development and registration strategy consulting, as well as preparation and approval services for new drug clinical trials (IND) and generic drug marketing applications (ANDA) based on NMPA and FDA. At the same time, Medicilon has professional IND and ANDA technical research team that can provide one-stop preclinical research, full project management and registration services, and has accumulated rich practical experience in dual-filing projects in China and the United States.
Medicilon is a professional preclinical integrated R&D contract research organization (CRO), providing a full range of one-stop R&D services, in compliance with international and Chinese filing standards, to pharmaceutical companies and institutions around the world.
Borrow a Boat To Go Overseas - License Out Opens a New Era of Racing
Obtaining approval of a new drug IND application from the US FDA is the ticket to getting innovative drugs overseas. If they want to truly enter the overseas stage, pharmaceutical companies must also face many challenges such as doubling the cost of conducting clinical trials overseas and an unfamiliar commercial environment. No matter how big the overseas market is, some pharmaceutical companies can only look back and sigh. The license out transaction model can not only quickly withdraw funds and supplement research and development, but also use various resources of overseas pharmaceutical companies to achieve complementary advantages, reduce the risk of new drug research and development, quickly enter the international market, and obtain abundant cash flow.
Therefore, the license-out model, which has lower thresholds, lower risks, and is more mature, has become an alternative for Chinese innovative drug companies.
According to incomplete statistics, as of December 21, 2023, there have been nearly 70 innovative drug license-out transactions in China in 2023, with the total disclosed transaction amount exceeding US 35 billion. This data has far exceeded last year. According to data from Kangcheng Capital, 44 license-out transactions for China’s innovative drugs occurred in 2022, with the disclosed transaction amount being approximately US 27.55 billion.
So far, Medicilon has successfully assisted a number of innovative drugs to successfully go overseas, and continues to pay attention to the overseas strategies and commercialization implementation of emerging pharmaceutical companies. Medicilon will continue to promote and accelerate the preclinical development of partners and helping innovative pharmaceutical companies expand their global footprint.
Whether it is building ships to go overseas or borrowing ships to go overseas, we must solve problems such as product homogeneity, innovation and differentiation, and improve R&D efficiency in order for the new drugs to go overseas market.
Riding the wind and going to overseas has a long way to go- See how Medicilon helps innovative pharmaceutical companies go overseas?
Products: How to create differentiated competitive advantages?
Financing: How to break through the funding bottleneck of new drug R&D?
According to statistics from the VBdata, in the first three quarters of 2023, a total of 128 financing cases occurred in China, a year-on-year decrease of 24%; the financing amount totaled RMB 36.174 billion, a year-on-year decrease of 54%. The investment and financing environment in the biopharmaceutical field has become significantly tighter. Financing is also a difficult problem on drug research and development.
In order to create a new investment and financing support platform and provide stable financial support for all aspects of new drug research and development, testing, and launch, Medicilon Academician Innovative Drug Maturation Center collaborated with a number of financial institutions to build a new drug investment and financing support platform which aiming to provide financial support for the research and development of new drugs.
R&D: Help advance the drug research and development process with high quality and efficiency
According to statistics from KPMG, under the premise that the drug efficacy remains unchanged, the market share of drugs launched for the first time reaches about 65%, followed by about 25%, and the market share of latecomers is very small. Therefore, going overseas is a battle of time, and speed is a very important element.
Medicilon is a professional biopharmaceutical comprehensive preclinical R&D service CRO, providing global pharmaceutical companies and scientific research institutions with a full range of one-stop new drug R&D services that comply with China and global filing standards. The service covers the entire process of preclinical new drug research, including drug discovery, pharmaceutical research, preclinical research and IND filing. By the end of 2023, Medicilon has provided drug research and development services to more than 2,000 clients around the world, and has participated in 420 new drug and generic drug projects that have been approved for clinical development.
Transactions: Facilitating the transaction of innovative drugs’ phased results
Achieving License out requires a very rigorous and complete BD business docking mechanism. According to public media reports and incomplete statistics, there have been 15 cases of “returns” among global pharmaceutical companies in the first three quarters of 2023, including 8 cases of Chinese pharmaceutical companies encountering obstacles in going overseas. The “return” incident reminds us not to be too optimistic.
In order to facilitate the transformation and trading of phased results of new drug research and development, the Medicilon Academician Innovative Drug Maturation Center has established an open and transparent new drug research and development trading platform to encourage more scientific researchers to invest in the research and development of new drugs and help scientific research results to achieve better results and rewards.
Good drugs know no borders, so it should go to a wider world! The successful construction or borrowing of ships to go overseas fully proves that the innovative research and development capabilities of Chinese pharmaceutical companies have been recognized by the international market. Medicilon will continue to improve its one-stop biopharmaceutical preclinical R&D service platform to lead the innovative drug companies to go overseas and help more innovative drugs to open the door of the US FDA and the international stage of biopharmaceutical!
