2023year3month25day-26On2023The China Improved Innovative Drugs Pearl River Summit Forum was held in Guangzhou. This summit invited managers from the domestic pharmaceutical industry, powerful pharmaceutical companies, and renowned academicians respected in the industry to gather together. Experienced and knowledgeable experts discussed and exchanged views on topics such as the interpretation and implementation of new policies and regulations, R&D project establishment strategies, formulation technology and clinical trials, analytical quality control and registration, pediatric medications, excipients and packaging materials, investment, etc.
Frost & SullivanFrost & SullivanLi Qian, Consulting Director of the Healthcare Business Unit at Frost & Sullivan (hereinafter referred to as 'Frost & Sullivan'), was invited to attend the event and delivered a speech on the current development status and future trends of improved new drugs.
Consulting Director, Healthcare Business Unit, Frost & Sullivan Greater China Li Qian
Li Qian pointed out that improved new drugs are based on the original drug and have better clinical application effects. Compared with already marketed drugs, improved new drugs can enhance drug efficacy, improve drug safety through process improvements, and make them more convenient for patients to use through the improvement of formulation technology, thereby increasing compliance.
The research data of known active ingredients in improved new drug candidates can be used to shorten the clinical research and development cycle, offering a higher 'cost-effectiveness' in terms of pharmacoeconomics. The success rate of their research and development is as high as that of new molecular entities.2.3Multiple times the input-output ratio is superior, and several products have already demonstrated promising commercial prospects. For example, AbbVie's leuprorelin acetate microspheres.2021Global sales17.9billion US dollars, with a market share of approximately64%-82%.
According to a Frost & Sullivan study, improved new drugs started their journey in the Chinese pharmaceutical market relatively late. However, driven by factors such as growing and upgrading treatment needs, favorable policies, and advancements in innovative formulation technologies, they have now entered a stage of rapid growth. .2020In China, the market scale of improved new drugs reached3,239.9RMB 10 billion, accounting for22.4%, is expected to arrive2030The market scale will reach7,951.7RMB 10 billion, accounting for26.6%In addition, companies engaged in innovative new drug development are also favored by the capital market. There are already many innovative new drug companies with market values in the global arena10For companies with over hundreds of millions of dollars, the investment and financing in China's improved new drug pipeline are also very active.
Data shows that in recent years, the number of registrations for improved new drugs has been on the rise year by year. As of2023year3month, and there are currently33Several improved new drugs have been approved for marketing, mostly2.2New dosage forms and routes of administration, yes185An improved new drug is in the clinical trial and marketing application stages, with therapeutic areas mainly focusing on anti-tumor drugs, cardiovascular system drugs, nervous system drugs, and anti-infective drugs.
"Innovative formulations are an important factor driving the growth of the market for improved new drugs," Li Qian further explained. Compared to traditional dosage forms, innovative formulations can improve medication compliance, enhance drug therapy, fill medication gaps, and reduce toxic side effects. Therefore, they account for the largest proportion in both approved and research portfolios. 2020In China, the market scale of innovative preparations reached1,326.7RMB 10 billion, accounting for41%, is expected to arrive2030In 2024, innovative formulations will account for nearly half of improved new drugs.
The administration routes of innovative formulations are diverse, meeting the clinical needs of different patients. Currently, the development of dosage forms for innovative formulations is diversified, with injections, sustained-release tablets, ophthalmic preparations, orally disintegrating films, and conventional tablets accounting for a relatively large proportion in the pipeline. According to Li Qian, the indications for innovative formulation products under research are extensive, mainly including anti-tumor drugs, nervous system drugs, and cardiovascular system drugs. However, unlike half of the approved innovative formulations that are only usedBEexperiment(Most are orally disintegrating film agents), Among the innovative preparations under research4A drug doesBEexperiment. SinceBEThe results of trials do not necessarily prove that a drug has clinical advantages. In the future, improved new drugs will only be approvedBEThe difficulty of conducting trials to support market launch will increase.
Li Qian pointed out, Innovative formulation products are continuously upgrading and iterating towards longer duration of efficacy and lower dosing frequencies. While enhancing the clinical advantages of products, they also help enterprises continuously occupy market share and extend the product lifecycle. At the same time, there will be more products of different new technology types for the same active ingredient, potentially In the future, it will change the market landscape of innovative preparations in our country.
In addition, there is an obvious gap in the development of innovative formulations in China compared to foreign countries. There are fewer domestically produced varieties of high-end formulations such as microspheres on the market. Under the premise of policy subsidies and equivalence, Domestic innovative formulations are expected to replace original research products with their price advantage.
"The development opportunities and challenges of innovative formulations coexist," said Li Qian. On one hand, after the launch of innovative formulations, their impact on collection is relatively limited. Can maintain high gross margins for a relatively long time, And as patients' payment levels improve, More and more patients are able to choose products with better efficacy and more convenient medication. At the same time, compared with innovative drugs, The innovative formulation is more in line with the hospital's medication habits. Conducive to the clinical promotion of domestic products after they are launched on the market. On the other hand, there are certain technical barriers to innovative formulations, and it is difficult to industrialize their technology research and development. It will test the enterprise's large-scale production capacity.
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About Frost & Sullivan's Healthcare Practice
The Healthcare Practice of Frost & Sullivan has professional analytical capabilities and extensive project experience in the life sciences. Leveraging Frost & Sullivan's global think tank resources and the cross-industry business development platform in Greater China, Frost & Sullivan Healthcare has unique core advantages in healthcare industry investment and financing services. Frost & Sullivan Healthcare has a wide range of corporate clients in China and in the past20In the year, a vast customer network was established, accumulating extensive project experience in various medical sub-sectors.
Project types include Knowledge Center projects (in-depth content, promotional activities).Pre-IPO financingprojectDCF modelValuation, Business Plan Services),IPO listingWe provide listed projects (industry consulting, clinical audits, fundraising and investment writing), market research, market value management and strategic consulting. We also cooperate with well-known domestic and international information platforms and investment and financing institutions, offering one-stop solutions for enterprises in specialized fields such as pharmaceuticals and medical devices. Our services have received wide attention from investors.
