According to incomplete statistics, as of2022year12month15Today, this year the National Medical Products Administration of ChinaNMPAThe number of new drugs approved has exceeded50Among them, most are small molecule drugs, as well as more than a dozen biologicsADCNew molecular therapies. On the other hand, from the second half of last year to now,AThe trend of the innovative drug industry in the A-share and Hong Kong stock markets has continued to be weak. Under the long capital winter, more innovative pharmaceutical companies have chosen to streamline their pipelines and start anew.
Under the predicament of R&D, commercialization, and funding, how should it be evaluated?2022What is the current development status of innovative drugs in China?2023What is the market outlook for innovative pharmaceutical companies in the future? How can innovative pharmaceutical companies achieve a breakthrough? Frost & SullivanFrost & SullivanChen Zhenrong, the consulting director for healthcare in Greater China at Frost & Sullivan (hereinafter referred to as 'Frost & Sullivan'), was interviewed by Huaxia Times to discuss the current development status and future trends of innovative pharmaceutical companies.
Huaxia Times
Q
Under the predicament of R&D, commercialization, and funding, how should it be evaluated?2022What is the current development status of innovative drugs in China?
2022The year 2021 may be the most challenging for Chinese innovative pharmaceutical companies since the outbreak of the COVID-19 pandemic. Whether it's the impact of repeated outbreaks on drug research and development, or the correction in the valuation of innovative drugs by primary and secondary markets, Chinese innovative pharmaceutical companies have borne too much pressure during this year.
However, we must also note that national policies are tilting towards supporting the research and development of innovative drugs. The market demand for innovative drugs is growing day by day, and the proportion of innovative drugs in China's pharmaceutical market has been rapidly increasing.2021In [year], the overall market scale of pharmaceuticals in China grew to15,912Yuan, of which innovative drugs account for approximately60%.
On the one hand, despite repeated outbreaks of the pandemic that have made clinical enrollment difficult and even led to problems with submitting materials, this has not stopped innovative pharmaceutical companies from moving forward.CDELooking at the first public announcement date of new drugs in clinical trials,2022Year-on-year2021The number of new drug clinical trials conducted each year has indeed declined, but the homogenization of new drug target layouts has also eased.2021Year revolves aroundPD-1/PD-L1New Drug Clinical Trials at the Target Site160one, and this number is2022The year has arrived110one.
On the other hand,2022Several domestic innovative pharmaceutical companies completed tens of millions of dollars in overseas investments last yearLicense expirationAuthorized Transactions. As of12In January, the number of China's innovative drugs authorized for overseas use has exceeded140Among them, the proportion of small molecules still accounts for a large part, including monoclonal antibodies, bispecific antibodies,ADCAntibody drugs, including those targeting the virus, also accounted for more than one-third, along with corresponding outputs from cell gene therapy.
Overall, 'Striving Forward' may be the narrative of Chinese innovative pharmaceutical companies2022The keyword of the year is that the capital market has cooled down2022The real challenges faced by innovative pharmaceutical companies in the year are evident, but at the same time, we should also see that Chinese innovative pharmaceutical companies are entering a period of harvest. This is evident not only in terms of the number of clinical trials conducted but also in terms of external licensing.
Q
2023What is the market prospect for innovative pharmaceutical companies in the coming year?
If we say2022The keyword for the year is "Forge Ahead", so2023The keyword of the year may be 'down-to-earth'. According to Frost & Sullivan's analysis,2025In China, the pharmaceutical market size will further grow to20,645Yuan, and the proportion of innovative drugs continues to expand to68%.
From a clinical perspective, there are still a large number of diseases for which there are no specific drugs; at the national level, biomedicine is both a strategic emerging industry and a pillar industry of China's national economy. Therefore, a series of favorable policies have been introduced to support innovative pharmaceutical companies. Therefore, with the emergence of more and more local independent innovation pharmaceutical companies, the weakening impact of the pandemic, and the implementation of international multi-center clinical trials, it is believed that2023The year will bring more opportunities for innovative pharmaceutical companies.
The correction in the pharmaceutical secondary market actually has two reasons. One is that innovative pharmaceutical companies face high uncertainties in research and development, making it difficult to provide reasonable valuations. The other is that the revenue or profits promised by pharmaceutical companies after product commercialization fall short of expectations. If they can be down-to-earth and accumulate over time, their financing situation and performance in the secondary market will receive reasonable evaluation.
Q
How can innovative pharmaceutical companies achieve a breakthrough?
At present, innovative pharmaceutical companies need to possess two core capabilities if they want to stand out from fierce competition: one is the underlying independent innovation capability, and the other is the commercialization implementation capability.
The underlying independent innovation capability is the core competitiveness of innovative pharmaceutical companies. At present, the homogenization of targets among innovative pharmaceutical companies in our country cannot be underestimated. The intense competition brought about by the rush to develop drugs is an inevitable result, and it also leaves potential risks for future product commercialization. This includes the possibility of facing negotiations with healthcare insurance and market competition leading to price cuts. Therefore, a differentiated target layout is a good direction.
Improved new drugs, compared to innovative drugs, have a shorter R&D cycle and lower investment costs. Additionally, they enjoy the right to set their own prices, which can help companies recover cash flow in the short term. Therefore, improved new drugs are also an area worth considering for innovation.
In terms of commercialization implementation capabilities, in addition to traditional sales methods such as ground promotion through hospitals, many enterprises have also chosen the overseas expansion strategy in recent years. Although there were early-stage innovative drug productsFDAAfter review, clinical trials still need to be supplemented, but it has nonetheless left valuable experience for subsequent enterprise products going global. At the same time,2022Chinese Innovative Pharmaceutical Companies in 2023license outTransactions are also showing an increasing trend. Entrusting overseas equity to multinational pharmaceutical companies or local enterprises with complete sales channels is also a good option.
Internally, in recent years, commercial insurance has also become an important partner for innovative pharmaceutical companies, with several innovative drugs subsequently included in the coverage of commercial insurances such as 'People's Welfare Insurance'. This year9In the month, the General Office of the State Council issued the first five-year special plan for universal healthcare - the '14th Five-Year Plan for Universal Healthcare Security'. It is clear that the concept of ensuring basic coverage should be upheld throughout, and the development of commercial health insurance is encouraged. In terms of improving support policies, it is proposed that 'commercial insurance institutions be supported in developing commercial health insurance products that are connected with basic medical insurance to better cover expenses not covered by basic medical insurance'. It is believed that under policy guidance, the payment directory for innovative drugs in commercial insurance will gradually improve, bringing practical benefits to patients while also helping Chinese domestic innovative pharmaceutical companies build a new platform for commercialization.
Overall, innovative pharmaceutical companies need to 'be strong themselves' if they want to make a breakthrough. Only by achieving fundamental independent innovation capabilities and commercialization skills can they overcome cycles, stay true to their original aspirations, forge ahead with perseverance, and ultimately see the dawn after the clouds clear.
*This interview was published in China Times, with reporter Sun Mengyuan. The original title was ' Innovative drugs that cannot be sold: The number of locally developed new drugs approved has dropped by 30%. Layoffs, delisting, selling off assets, and bankruptcy have become commonBiotechaliveGo Down Options |2022China Economic Yearbook >> (Click on "Read the Original Article" at the end of the text to view the full report).
