In recent years, with the reform of the pharmaceutical review and approval system, the innovation enthusiasm of China's pharmaceutical industry has been ignited, and a large number of outstanding biomedical enterprises have emerged, which in turn has promoted the development and progress of the entire pharmaceutical industry, and enterprises have continued to develop innovative drugs and new medical technologies.
Among these biomedical companies, CStone Pharmaceuticals is a unique presence. Founded at the end of 2015, CStone has emerged in the industry, and successfully landed on the Hong Kong Stock Exchange in 2019, so far the company has successfully introduced three innovative drugs to the market, including two similar first-of-its-kind precision therapeutic drugs Phukethua (Pratinib capsules) and Taijihua (alvatinib tablets), and a potential best-in-class tumor immunotherapy drug Zejiemei (Sugli maclizumab injection). At the same time, CStone has established a rich product pipeline consisting of 15 tumor drug candidates, and its R&D layout is evolving from 1.0 to a 2.0 stage that pays more attention to source innovation and differentiation.
How to layout commercialization is another difficulty for innovative pharmaceutical companies after research and development, and in the commercial layout, it can be said that CStone Pharmaceutical is also at the forefront of the industry. How did CStone Create "Cornerstone Speed"? How does the company view the current environment for the development of the domestic biomedical industry? What kind of layout will the company have next?
"We are still in the best era of China's innovative pharmaceutical companies, and the research and development and commercialization speed of local innovative pharmaceutical companies should be faster, and faster." Zhao Ping, general manager of CStone Pharmaceuticals Greater China, said in an exclusive interview with reporters recently.
Before joining CStone, Zhao Ping single-handedly led the listing of the BMS star drug "Opdivo" in China, the full name of "O Drug", which is also the first PD-1 anti-cancer drug to be listed in China. In addition, she has successfully listed more than 30 products in China, many of which have become leaders in segments such as oncology, rare diseases and medical aesthetics. As an experienced "veteran" in the management and commercialization of companies in the domestic pharmaceutical industry, CStone's commercialization strategy is closely related to her.
Tumor treatment tends to be precise, and the initial results of commercialization are satisfactory
At present, CStone Pharmaceuticals has obtained approval for five new drug listing applications worldwide, Chinese mainland three, one in Hong Kong, China, and one in Taiwan, and many late-stage drug candidates are in the critical clinical trial or registration stage.
Reporter: Can you briefly introduce your experience in the industry?
Zhao Ping: I am an early practitioner in the pharmaceutical industry, from 1993 to the present, before that I have been an obstetrician and gynecologist for several years, carefully calculated that there should be 27 years, all the way to witness the rapid development of China's pharmaceutical industry.
From a doctor to a marketing director in the pharmaceutical industry in the early 90s, he first joined BMS and then to Eli Lilly, starting from grassroots work, becoming the youngest vice president in the industry at the age of 35, then becoming mncical's first Chinese general manager at the age of 40, and the general manager of Greater China in jianzan, Allergan, BMS, and CStone for the past 12 years. My career development is a history of the growth of local talents after the reform and opening up, and also witnessed the increasing academic level of our country's pharmaceutical industry, and grew up with many well-known experts in China today, step by step to the international stage.
Over the years, I have been at the forefront of pharmaceutical innovation, from rare diseases, oncology drugs, medical beauty to the current innovative drug companies, basically every popular industry, are the earliest involved, it can be said that I caught up with every "good time" in the development of the domestic pharmaceutical industry, from reform and opening up, to the current domestic biomedical industry innovation, I think, whether from the external environment, policy aspects, or talent reserves and other dimensions to measure, is currently the best time for the development of the biomedical industry.
Reporter: In the first half of this year, CStone Pharmaceuticals had two innovative drugs approved for marketing in Chinese mainland, namely pratinib and alvatinib, can you specifically introduce the highlights of these drugs and the current progress of commercialization?
Zhao Ping: Pratinib and avatinib are targeted drugs for precision therapy, of which pratinib is the first highly selective RET inhibitor approved for marketing in China, and the approved indication is for the second-line treatment of non-small cell lung cancer, and the application for the treatment of thyroid cancer and medullary thyroid cancer has been accepted by the China Food and Drug Administration and is currently under review. Avatinib is the world's first KIT/PDGFRA inhibitor of its kind, the first approved and the world's first precision treatment drug for PDGFRA exon 18 mutant gastrointestinal stromal tumor (GIST), and has been approved as an indication for advanced systemic mast cell hyperplasia in the United States.
From a commercial point of view, both drugs have achieved good results and have been included in commercial insurance in more than 60 major provinces and cities. It is worth mentioning that praratinib performed excellently, and more than 200 patients in nearly 100 hospitals used this life-saving drug on the first day of listing.
Tumor treatment is slowly moving towards precision treatment, that is, genetic testing is carried out from the beginning to find the patient's correct genetic target mutation and the most effective treatment method, and ultimately enable tumor patients to achieve long-term survival like patients with chronic diseases. We want more doctors to realize that all tumor patients, including lung cancer patients and gastrointestinal stromal tumor patients need to do genetic testing at the beginning of diagnosis, because this can allow patients to get the most effective precision treatment drugs at the first time, so as not to delay the disease and lose the opportunity for treatment, so we have invested a lot of work in carrying out doctor education and patient education.
Reporter: Next, what other new drugs will enter the commercialization stage of the company?
Ping Zhao: CStone pharmaceuticals is constantly developing innovative products, we have 15 products in research, but also constantly expand the indications of the current drug. With the further deepening of precision treatment research, the concept of "co-treatment of different diseases and heterogeneous treatment of the same disease" has gradually been introduced. The basket experiment we're conducting is to see if the same gene expresses different cancers that work for pratinib. Pratinib is laid out in the first line of indications for the treatment of non-small cell lung cancer, as well as indications for medullary thyroid cancer and thyroid cancer. Recently, the gastrointestinal precision treatment drug AYVAKIT has been approved in Hong Kong, China, and is the first precision treatment drug for patients carrying PDGFRA D842V mutant GIST in Hong Kong, China. Suglizumab is also considering expanding new indications that are expected to become potentially effective global PD-L1 for both stage III and STAGE IV NSCLC, as well as potential efficacy for gastric, esophageal cancer and lymphoma. In addition, our other first innovative drug of the same kind, Avenib, will be approved for listing, which is also the drug we will exert our strength, the drug indication is relapsed or refractory acute myeloid leukemia, which is the first drug in China, and last year was also included in the "list of urgently needed overseas new drugs (the third batch)", with huge market expansion space.
Industry policy blessing New drugs are accelerated on the market
Since 2015, in the context of the national new medical reform, the drug review and approval system is also constantly innovating, one of the important manifestations is the review speed of innovative drugs, taking praratinib as an example, it took only 6.5 months from NDA acceptance to approval, which was shortened by half compared with the industry average approval time of 13.7 months; on the other hand, the emergence of the Boao pilot area made pratinib the first innovative drug approved through boao real-world data assisted review.
Reporter: Do you think that the domestic oncology drug development and market environment has left enough room for enterprise innovation?
Zhao Ping: In recent years, many new policy innovations have emerged, which has made our eyes shine, and these policies have paved the way for the development of the pharmaceutical industry from multiple levels such as talent introduction, drug research and development, and entrepreneurship landing. It can be said that China's pharmaceutical policy innovation is also accelerating.
Specifically, the policy aspect is very effective is the improvement of the review and approval policy, the State Food and Drug Administration to accelerate the clinical trial application and new drug listing application approval process, which creates a good regulatory environment for new drug research and development, and regional policies are getting better and better, local governments implement central policies and supplement them, to build the unique advantages of each region in the pharmaceutical industry. In addition, in terms of talents, China is rapidly gathering top academic talents, most of whom are returnees with overseas academic backgrounds, who have become a new force in China's pharmaceutical innovation.
At present, the innovation of medicine still needs to continuously improve the basic research capabilities, and continue to innovate in market access and payment to create a perfect ecological environment.
Reporter: Some people think that the "Guidelines for Clinical Research and Development of Clinically Value-Oriented Antitumor Drugs" issued by the CDE (Drug Evaluation Center of the State Drug Administration) means the beginning of the supply-side reform of innovative drugs.
Zhao Ping: The CDE's policy document further clarifies the constraints on pharmaceutical companies to ensure that after the drug is listed, it can truly benefit patients, which will help to truly focus on the development of innovative drug companies and bring high-quality innovative drugs to patients.
At present, me-too drugs themselves are a new class of drugs developed based on the original research drugs and after circumventing the latter's chemical structure patent. The strong imitation ability of domestic pharmaceutical companies and the concentrated investment of short-term capital have caused excessive competition in domestic me-too drugs. With the continuous improvement of policies, such situations will be effectively improved through market-oriented adjustments in the future, and capital will also be invested in truly innovative drugs.
Reporter: How do you evaluate the current situation of overseas licensing by Chinese enterprises? What are the company's expectations for overseas markets in the future?
Zhao Ping: At present, most of China's innovative pharmaceutical companies have not yet begun to make a profit, mainly due to the long new drug research and development cycle, from the screening of ideal molecules or potential antibody drugs to the successful listing, generally speaking, it takes nearly a decade, and innovative research and development is also accompanied by many risks of failure. In addition to the licensing of commercialization rights, how to achieve a relative balance between input and output, innovation and success, the development rights of early clinical stage products or the technology platform License out is one of the ways to promote the development of the industry at present, and it is also in recent years that the drug research and development of domestic pharmaceutical companies will also help to achieve commercial returns in advance.
The consensus generally formed by capital, industry and policy people is that China's innovative pharmaceutical companies will become a trend, and there will be more and more overseas licensing projects, in the face of the ever-changing payment environment, financing and capital exit channels, how to choose between focusing on the domestic market and internationalization, layout internationalization strategy, how to decide on business expansion projects, choose partners, etc., still need to be further explored by Chinese innovative pharmaceutical companies.
As far as CStone Pharmaceuticals is concerned, at present, we are cooperating with the American company EQRx, CStone Pharmaceuticals will CS1003 (PD-1), Zejiemei (Schugli mammab, PD-L1) foreign rights and interests to EQRx, on the one hand, it shows that overseas markets recognize our innovation, on the other hand, we are also using the advantages of partners to open up all aspects of commercialization in an innovative mode, improve drug accessibility, and then gain overseas market share.
Reporter: In the future, what new plans does CStone have in terms of commercial expansion?
Zhao Ping: We will formulate strategies according to the market information we have. 2021 is the first year of the company's commercialization, the planning of the commercial team covers 70-80% of the national market, the entire commercialization team is close to 300 people, covering more than 30 provinces, about 100 cities, of which the first and second tier cities have achieved full coverage, and the third and fourth tier cities are selectively covered according to economic level, population size and other factors. In terms of hospitals, we have referred to the historical sales distribution of comparable products, and comprehensively considered the clinical KOL communication, as well as the professionalism of key departments, the number of patients and other factors, and the first batch also covered more than 400 hospitals.
With the improvement of market education, the popularization of genetic diagnosis, and the improvement of patients' ability to pay, we will gradually adjust our commercial deployment strategy to maximize the commercial potential of these drugs to benefit more patients.
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