Investment trend of improved new drugs: predict future growth points and risk points!

Aiming at future growth opportunities Pharmaceutical Economics News: Improved new drugs are considered to be one of the directions in line with the transformation and upgrading of China's pharmaceutical industry
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However, its value was once underestimated in China.
In recent years, it has greatly improved, and it has also attracted more and more companies to enter.
What are the opportunities for the future growth of improved new drugs? Su Zhigui: While China's improved new drugs usher in a blue ocean of development, there is still huge room for development
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In the future, it is necessary to continue to develop more improved new drugs based on clinical needs
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One is the field of chronic diseases
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With the aging of the social population, the number of patients with chronic diseases increases.
Chronic diseases usually require long-term medication, which has higher requirements for safety and compliance than short-term medication, and there is an urgent need for improved drugs
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The second is the field of children's medicine
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There is a shortage of children's medicines, and the three-child policy is open, and the domestic market for children's medicines is in huge demand
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Enterprises can develop new improved chemical drugs for children according to the characteristics of children's growth and development and the needs of pediatric clinical practice
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The third is to reduce the cost of medical care
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Enterprises can also use improved new drugs to make the process of medical care and medication more convenient, thereby further improving service quality and reducing medical care costs
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Fourth, the application of new drug delivery systems and new technologies to the development of improved new drugs can lead to breakthroughs in safety and efficacy, and is also an opportunity point in the future
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For example, the albumin-bound paclitaxel prepared by the innovative technology of albumin nanotechnology is significantly improved in safety and efficacy, and also greatly shortens the time required for injection and reduces the burden of medical care
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Fifth, the use of artificial intelligence to discover new uses of old drugs will be a development direction worthy of attention on the road to drug improvement
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Li Youxin: At present, improved new drugs are facing unprecedented development opportunities under the three driving factors of demand side, policy side and technology side, which will be the future trend of new drug research and development in China
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On the one hand, because there are very few domestic companies that make Class 1 innovative drugs; on the other hand, improved new drugs re-innovate the already marketed drugs to meet clinical needs, achieve efficiency enhancement and detoxification, improve patient compliance, and enhance product intrinsics.
Quality, high-quality products serve the clinic
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Future opportunities for improved new drugs: First, changes in therapeutic areas
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In recent years, great changes have taken place in the field of indications for improved new drugs under research
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In the past, the indications of improved new drugs under research were usually in the fields of schizophrenia, pain, ADHD, Parkinson’s, epilepsy, and other neuropsychiatric fields, as well as in the field of ophthalmic drugs.
There were also improved new drugs on the market for chronic disease indications such as hypertension and cardiovascular disease
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Now, improved new drugs are gradually being developed for cancer and orphan drug indications, and the number of improved new drugs for diabetes has also increased significantly
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The second is the advancement of formulation technology
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Formulation technology is a crucial factor
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At present, various products such as microspheres and liposomes have been launched on the market.
Domestic technologies are already in line with foreign countries.
In the future, precise targeted preparations and intracellular delivery preparations are also gradually maturing
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The third is the R&D and production capacity of excipients
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For sustained and controlled release formulations, the carrier material is critical
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For example, for the PLGA required for microspheres, many companies that want to do this now can only use excipients from foreign suppliers.
In fact, the quality cannot be well controlled, and the quality of the final preparations is also difficult to control
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Therefore, the self-research and production of key excipients is an important part of the research and development enterprises of improved new drugs
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Fourth, the overall R&D strength has been improved
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If only the improvement of drug delivery system (DDS) is carried out without the advantages of synthesis and improvement of new active ingredients (API), the space is limited and it is difficult to achieve the expected market size
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An ideal improved new drug R&D platform should have clinical research capabilities for new drugs, the ability to synthesize and improve new APIs, and an integrated platform with multiple DDS technical means.
clinical needs
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Guo Dongsheng: Under the background that the state encourages innovation and supports the innovation of drugs that are oriented by clinical value and have clear or special curative effects on diseases, the improved new drugs have a certain clinical foundation, and most products do not need to do more than innovative drugs.
Early-stage exploratory clinical trials, and even confirmatory clinical trials can draw on completed clinical trials
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However, the requirements for clinical trial design are still very high, requiring a professional design team and design software
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Opportunities for the future growth of improved new drugs: First, the children's drug market
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There is a huge unmet need for medicines for children due to the lack of suitable dosage forms or drugs
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No matter in terms of "quantity" or "quality", there is a huge market space for children's medicines
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The second is the rare disease market
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As the saying goes, "rare diseases are not rare"
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In addition to the 121 common rare diseases included in the first rare disease catalogue, there are thousands of rare diseases
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The research and development of improved new drugs can focus on related diseases to fill the gap of domestic related rare disease treatment drugs
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This is also in line with the "14th Five-Year Plan for National Drug Safety and Promotion of High-Quality Development", which encourages the research, development and marketing of new drugs with clinical value and clinically urgently needed generic drugs, and innovative drugs with obvious clinical value.
Medicines urgently needed clinically for malignant tumors, major infectious diseases, rare diseases and other diseases, as well as medicines for children, will be reviewed and approved with priority if they meet the conditions
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Suggestions for Promoting Orderly Research and Development” Pharmaceutical Economics News: What are your suggestions for promoting the orderly research and development of improved new drugs in China? Jin Fang: It turns out that everyone has always believed that compared with innovative drugs, improved new drugs have newer markets, faster research and development, and less investment The three major characteristics are not necessarily the
same.
Improved new drugs also face long cycles, large investment, and high risks, and because the protection barriers of improved new drugs are not high, there are many clinically failed projects
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In such a market environment , the improved new drugs must be developed in an orderly manner
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For example, when the use frequency of long-acting preparations is improved from 1 day to 3 to 4 days, CDE directly and explicitly requires that it is more clinically valuable to make it into a week or a month, otherwise patients will easily remember when to take the medicine
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In addition, for enterprises, the development of new and improved drugs must have accumulated experience and a deep understanding of clinical practice
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In the Chinese market, there are still a large number of unmet clinical needs.
Enterprises should strengthen communication with clinicians, seize clinical pain points, and deepen and strengthen in the fields of indications they are good at
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To sum up, we still need to focus on clinical advantages, make targeted improvements to the needed drugs, flexibly use data borrowing strategies, scientifically reduce R&D costs, and shorten the R&D cycle
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At the same time, it is also necessary to design a most effective and efficient regulatory path to obtain approval for listing
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In this process, technical barriers and patent protection should also be established to further extend the life cycle of products, so as to enter a virtuous circle of development
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In this regard, companies need to clarify clinical needs, conduct comprehensive project approval considerations, build a solid technology platform and R&D strategy, and provide society and patients with more effective, safe, and adaptable improved new drugs
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Su Zhigui: China emphasizes that improved new drugs need clear clinical advantages
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From a regulatory perspective, more and better drugs can be provided for patients and doctors; from an enterprise perspective, the development of improved new drugs with significant clinical advantages under strict requirements requires greater investment.
Therefore, in order to encourage continuous innovation, it is necessary to Provide reasonable support for improved new drugs at all levels of policy
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Judging the clinical advantages of improved new drugs should proceed from a multidisciplinary perspective
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To evaluate whether there is a real clinical advantage, it may require the joint efforts of clinicians and nurses, pharmaceutical registration experts, pharmacy experts, clinical statistics experts, etc.
, which is conducive to the unification between regulatory authorities and enterprises
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"Encouraging innovation + emphasizing clinical value" is the overall orientation of improved new drugs
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From the perspective of drug research and development, if the project meets the clinical needs, the next step is to focus on the product development strategy and the design of clinical trials.

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In addition, how to reflect their own advantages and minimize time and capital costs is also a key issue for enterprises to consider
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Li Youxin: From a trend point of view, because the national policy is oriented towards encouraging innovation and emphasizing clinical value, the number of research and development of improved new drugs will definitely increase significantly in the future
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This requires companies and drug review centers to check carefully.
Companies should not blindly develop projects.
They must first find a suitable direction to solve unmet clinical needs for product development based on clinical needs, and standardize the establishment of their own from CMC, PC to clinical.
R&D capability
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It is also hoped that the Center for Drug Evaluation will issue more guidelines to facilitate the orderly development of improved new drugs
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The improved new drugs of high-end preparations avoid low-level repetition to a certain extent, but there is still a big gap between the innovation level of preparations in China and foreign countries
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The innovation of the drug release system is actually inseparable from the innovation of formulation technology, pharmaceutical excipients, drug delivery devices, formulation equipment, testing equipment and packaging materials.
Continuously promote the healthy and orderly development of the industry
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Guo Dongsheng: Improved new drugs are the optimization of marketed drugs with known active ingredients.
Therefore, the development of improved new drugs should pay more attention to clinical advantages, including better efficacy, safety, and convenience
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The orderly research and development of improved new drugs means that when the project is established, it is necessary to carry out differentiated research based on the characteristics of the product and the orientation of clinical value to better serve the clinic
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Do not proceed from the perspective of the market, which leads to waste of resources and blindly following the trend
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Under the background of accelerated innovation and development of pharmaceutical companies and policy support, the improvement of marketed products to increase their clinical value will be a main battlefield for future drug innovation
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