From the beginning of the pharmaceutical industry, to the leading generic drugs and today's upstart on the science and technology innovation board, and the dark horse of innovative drugs, Yuekang seems to have stepped on the key node of the development of the pharmaceutical industry at every step. Behind the "reassuring" performance, Yu Weishi is leading Yuekang to grow into a real "enterprise of the times".
The thing I am most dissatisfied with is myself. ”
One morning in the early winter of Beijing, in an office at the Yizhuang headquarters of Yuekang Pharmaceutical Co., Ltd., Yu Weishi, chairman of Yuekang Pharmaceutical Group (hereinafter referred to as "Yuekang"), recalled that in the more than 20 years since the establishment of the company, his words were full of expectations for the unknown and "dissatisfaction" with the past.
The years have not left many traces on the face of the chairman of the "80s", about the achievements and brilliance that Yuekang has achieved, Yu Weishi does not want to talk more, and does not say some business management as a superior. What's more, he repeatedly elaborated on his understanding of drug research and development, the future of the pharmaceutical industry and the plan of "Centennial Yuekang" to the reporter Rong **, the manager of e-drug.
Yu Weishi, chairman of Yuekang Pharmaceutical Group: "I think that the company (Yuekang) has not gotten better today, which is far from my goal. ”
It is precisely because of Weishi's "dissatisfaction" that today's Yuekang is very different from a few years ago: nucleic acid drug pipeline, the first 1Class 1 innovative drugs, CRO business ......It is no longer appropriate to judge the value of this company from the perspective of the past.
If you count the development history of Yuekang, from the beginning of the pharmaceutical industry, to the leading generic drugs and today's upstart on the science and technology innovation board, and the dark horse of innovative drugs, Yuekang seems to have stepped on the key node of the development of the pharmaceutical industry at every step.
For more than 20 years, Yu Weishi and Yuekang have been keeping up with the development of the industry and changing, but in Yuekang's genes, there are also things that have not changed for decades. "To make medicine, we must adhere to the principle that the quality of drugs is only 100 points, and 99 points is equal to zero'. This sentence is written on every wall of Yuekang, and in the management of Weishi, there is no room for bargaining for the pursuit of quality.
It is an undeniable fact that Yuekang is moving towards a path of transformation of traditional pharmaceutical companies with its own logic. Yu Weishi is also leading Yuekang to grow into a real "enterprise of the times".
Innovate and move forward at full speed
In the 80s of the 20th century, Yu Weishi, who went out from Taihe, quickly opened the market by relying on the largest cephalosporin single product. Surprisingly, he went north when his development was smooth, and settled in Beijing Yizhuang to start the industrial era of Yuekang.
At the beginning of its establishment, Yu Weishi gave full play to its advantages and embarked on a development route based on the production of cephalosporins. Soon, the sales of many cephalosporins under Yuekang exceeded 100 million yuan. Since then, Yu Weishi has targeted omeprazole, ginkgo biloba extract injection, lansoprazole for injection and other products, and made these varieties the leader of the same product in the domestic market.
On August 18, 2023, Yuekang released its semi-annual report: the total revenue in the first half of the year was 2.2 billion yuan, a year-on-year increase of 1405%；Net profit 20.7 billion yuan, an increase of 4760%；The non-net profit attributable to the parent company was 200 million yuan, an increase of 621%。Under the cold winter, such a report card is undoubtedly "reassuring" for the market and shareholders. However, peeling off the coat of industry, you will see the innovative background of Yuekang.
Under the strategy of "R&D generation, reserve generation, and transformation generation", Yuekang's Alux, Ginkgo biloba extract injection, Huoxin Pill (concentrated pill), hydroxysafflower yellow pigment A for injection and other major products will soon become an important part of Yuekang's star product line.
Among them, Alex, as Yuekang's first self-developed Class 1 new drug, has been successfully marketed**Acute ischemic stroke injection of hydroxysafflower yellow pigment A,** compound ginkgo biloba leaves for vascular dementia and** post-infection cough (wind-chill lung disease) Zihua warm lung cough granules have completed the clinical trial and will soon apply for NDA;**YKYY017 nebulized inhaler for novel coronavirus infection is in clinical trials;**CT102 is in ongoing clinical ...... for primary liver cancerTake hydroxysafflower yellow pigment a for injection as an example, as 1The results of clinical studies completed in 2 types of innovative traditional Chinese medicines have shown that hydroxysafflower yellow pigment A can significantly improve the neurological deficit in patients with acute ischemic stroke, with definite efficacy and good safety.
In addition to hydroxysafflower yellow pigment A, Yuekang's Class 1 innovative Chinese medicine also includes compound ginkgo biloba leaves, purple flower warm lung cough granules, Peitu Qingxin granules and Heskin anti-itch gel.
According to Song Gengshen, President of the Pharmaceutical Research Institute of Yuekang Pharmaceutical Group, at present, Yuekang has 18 innovative drug projects under development, and the pipeline focuses on three key areas such as cardiovascular and cerebrovascular diseases, tumors and infectious diseases, consolidating and consolidating the four major technical routes of nucleic acid drugs, peptide drugs, small molecule drugs and characteristic traditional Chinese medicine preparations, and actively laying out the innovative drug research and development pipeline through independent research and development, cooperative development, external introduction and other ways, accelerating the breakthrough of innovative drug research and development, and forming a differentiated competitive advantage.
After more than 20 years of rapid and high-quality development, Yuekang has established its own unique advantages, especially the precipitation of unique business vision and variety selection ability, the existing varieties and varieties under development are based on market needs and clinical needs for promotion and research and development, so that the existing products can be launched to the market at the fastest speed, and also for the commercial layout of the varieties under development.
R&D is further increased
Speed is the most admirable thing about Yuekang and Yu Weishi. Yu Weishi, who is about to celebrate his 80th birthday, still insists on driving by himself. In the dialogue with Yu Weishi, the deepest experience is that this business leader who is about to enter his old age is full of curiosity and drive.
Under his leadership, Yuekang is also running into a new track.
The first 1The Class 1 innovative drug Alux was approved for marketing, breaking the gap in the field of newly approved innovative drugs of YuekangActively deploy mRNA vaccines and small nucleic acid drugs, and comprehensively cut into the nucleic acid track;Introduced peptide drug R&D pipeline ......Yuekang has a multi-point layout in the field of cutting-edge research and development.
For Yuekang, for more than 20 years, Yuekang Pharmaceutical R&D Laboratory has once again entered the "no man's land" of domestic innovative drug research and development, from building its own factory to producing generic drugs, to moving towards the combination of generic drugs, and then to increasing the research and development of innovative drugs with the help of the capital market.
With the emergence of key technological breakthroughs and blockbuster drugs, nucleic acid drugs have become the hottest field of biomedicine, and there is a great potential to form the third revolutionary wave of modern pharmaceuticals after small molecule drugs and antibody drugs, demonstrating great development potential and social and economic value.
In February 2021, Yuekang wholly acquired 100% of the shares of Hangzhou Tianlong Pharmaceutical, which is mainly engaged in the research and development of nucleic acid drugs, and its chemical drug Class 1 new drug CT102 is China's first fully self-developed antisense nucleic acid (ASO) drug, lyophilized dosage form, for primary hepatocellular carcinoma. Through the acquisition, Yuekang has truly entered the track of nucleic acid innovative drugs. In January this year, CT102 completed the phase 102 clinical study, and in March, it initiated the clinical trial A.
In addition to the pipeline itself, Yuekang is making every effort to build a drug development platform. It is worth noting that in April 2022, Yuekang obtained the company's first important patent for nucleic acid drug delivery system. In order to solve the problem of the bottleneck of the LNP delivery system, the company has fully invested in the research and development of nucleic acid platform delivery system technology, and so far Yuekang has been authorized 10 patents for nucleic acid drug delivery system, covering LNP-related patents and galnac core patents that can meet the different delivery needs of nucleic acid drugs.
In July this year, Yuekang completed the filing and registration of cationic lipid excipients (YK-009) with independent intellectual property rights on the registration platform of CDE's original and auxiliary packagesIn October, YK009 was registered in FDA DMF, and Yuekang became the first domestic enterprise to complete the domestic and foreign filing of cationic lipids with independent intellectual property rights. The company has not only formed a systematic patent layout in the field of LNP delivery technology, but also simultaneously realized the large-scale production of excipients, which will not only accelerate the progress of the company's nucleic acid drug pipeline, but also provide support for the majority of nucleic acid drug companies at home and abroad, which is an important milestone for Yuekang nucleic acid drug platform.
The company has completed the construction of a nucleic acid drug-based target discovery platform, a high-throughput screening platform, a leading process development and large-scale preparation platform, and a complete analysis and quality control platform, and has carried out a systematic layout in the underlying key technologies of nucleic acid drugs such as AI target discovery, sequence optimization design, LNP delivery, galnac delivery, extrahepatic targeted delivery, nucleoside monomer modification, and co-capping, and strengthened the target screening and confirmation, sequence design, antigen design, efficacy evaluation, CMC small test and pilot test, R&D capabilities for the whole chain from clinical trials to registration and application.
In addition to fully entering the nucleic acid track, Yuekang also introduced a peptide drug R&D pipeline in January 2022 to fully advance into the field of modern biomedicine.
Song Gengshen said, "The era of a single product has passed. Platform technology is the core competitiveness. Yuekang has been committed to the public relations of key platform technologies, in addition to the delivery system, we have also made breakthroughs in a series of key platform technologies related to nucleic acids. These key platform technologies form the core technology platform, and we will make a series of products around the core technology platform. ”
The confidence of talents
Behind the innovation, Yuekang has a strong talent team and a mature management system. In order to support R&D, Yuekang actively introduces high-level scientific and technological innovation and entrepreneurship talents, and pays attention to talent training. At present, there are more than 500 R&D teams, more than 70 doctors and professors, and the core team members come from Tsinghua University, Peking University, Chinese Academy of Sciences, Academy of Military Sciences and other well-known universities at home and abroad.
In addition, Yuekang gives full play to the technical advantages of academician expert workstation, postdoctoral workstation, doctoral supervisor workstation and national enterprise technology center, and has built a perfect school-enterprise joint innovation and achievement transformation mechanism. For example, Academician Zhang Boli is the chairman of the DMC of the phase A clinical trial of hydroxysafflower yellow pigment, Academician Wang Fusheng led the clinical related to the small nucleic acid drug CT102, Academician Chen Keji is the general consultant of the Huoxin Pill (concentrated pill) project, Academician Wang Chen and Professor Cao Bin co-led the phase clinical trial of peptide peptide inhibitor for the prevention of new crown membrane fusion, Academician Zhao Jizong and Academician Jiang Jiandong are the chairman of the DMC of the phase clinical trial of compound ginkgo biloba leaf ** vascular dementia, and Academician Han Demin took the lead in launching Yuekangtong** In addition, in the process of drug research and development, academicians and experts give guidance on product research and development projects and key points, and doctoral students from colleges and universities serve as the backbone to form an efficient R&D echelon.
Taking Kechuang Dingcheng, a subsidiary of Yuekang Science and Technology Innovation, as an example, there are more than 180 employees, including two professors, 10 doctors, 38 medical masters, and 33 with master's degree or above3%, such an "ingredient list", full of gold.
What the outside world doesn't know is that Kechuang Dingcheng was not established in the past two years, but has grown all the way with the development of Yuekang.
When Kechuang Dingcheng was established in 2012, the development of China's innovative drug industry was still in the ignorant stage, and the domestic CXO industry was just starting. Yu Weishi's step is low-key and not caused by people. However, Yu Weishi is well aware that clinical trials are the only way for drugs to be marketed, and a large number of clinical trials are put into practice every year.
Facts have proved that Yu Weishi once again bet on the "treasure". In 2015, the "7.22 incident" shook the industry, and it also began to make everyone realize the importance of CRO. After two years of adjustment, the CRO industry has gradually recovered since 2017, the number of clinical trials has gradually increased, and the industry has entered a period of rapid development. Under the increasingly fierce competition in the industry, major pharmaceutical companies have increased their weight in drug research and development, especially the development of innovative drugs, and the importance of the CRO sector to Yuekang is self-evident.
Wang Xia, general manager of Kechuang Dingcheng, said that the original intention of Yuekang to establish Dingcheng is to speed up the transformation and implementation of Yuekang's clinical research projects, save the commercialization process of pure CRO companies, make breakthroughs in quality and progress, and speed up and increase efficiency for the group's clinical R&D projects.
Wang Xia still remembers that despite all kinds of pressure, Yu Weishi never hesitated to invest in the CRO business. He has repeatedly emphasized that R&D is a race for time, and he is more eager than anyone else to see our growth. It is the chairman's attention that Kechuang Dingcheng has a huge living space today. ”
At the end of 2021, Kechuang Dingcheng completed the national certification and obtained the national high-tech enterprise qualification, which is a historic event that has accelerated the company's professionalization process. Up to now, Kechuang Dingcheng has obtained exact cooperation with many well-known academicians in the medical field such as Wang Fusheng, Zhang Boli, Chen Keji, Chen Xiaoping, Han Demin, Wang Chen, Du Guanhua, Guo Yinglu, Jiang Jiandong, Zhao Jizong, etc., to actively develop professional research and development products for Yuekang's clinical research and development work, and to lay out high-end traditional Chinese medicine preparations, innovative drugs and chemical drugs and the future biological chain industry.
Regarding Yu Weishi, Wang Xia commented: "Sometimes I don't agree with his concept, and I have also experienced a run-in period. But later I realized that he made a big move on the next move. ”
R&D is the best story
In the highly competitive pharmaceutical industry, Yuekang is certainly not completely "perfect".
In December 2020, Yuekang was listed on the Science and Technology Innovation Board of the Shanghai Stock Exchange, and Yu Weishi, who has always liked to "be a low-key person and do things in a high-profile manner", once said: "Listing is just the beginning of Yuekang, and the company should increase its innovation efforts, adapt to innovation needs, and create a new innovative drug product pipeline."
If you take Yuekang's business apart, whether it is traditional Chinese medicine innovative drugs, nucleic acid drugs or the current hot CRO business, each part is a hot spot that the market is chasing. Regarding the outside world's doubts about the "market value", Yu Weishi said indifferently that for Yuekang, listing is only one of the strategies and tools for the company's operation, and the way for enterprises to be responsible for the market and shareholders is not only to tell stories. Only by continuously investing in product research and development can the company make profits unbreakable.
The doubts from the outside world don't stop there. It has been nearly a year since the "Class B and B Pipe" landed, and the new crown epidemic seems to have gradually subsided and faded out of public view. In addition to the new crown, discussions about respiratory pathogens such as influenza and Mycoplasma pneumoniae have been frequently searched this year.
In May this year, Yuekang announced that its YKYY017 nebulized inhaler for the prevention and treatment of new coronavirus infection has been approved by the US FDA for phase clinical trials, and has passed the clinical trial filing of the Therapeutic Goods Administration (TGA) of Australia, and the phase clinical trial study was also launched in the China-Japan Friendship Hospital in August this year.
Why is Yuekang still insisting on investing in new crown products?
The pandemic no longer constitutes a Public Health Emergency of International Concern (PHEIC) and is no longer a "pandemic", but that doesn't mean it doesn't exist. Globally, the pandemic is still in place. New models from researchers such as Rustom Antia of Emory University reveal that the coronavirus may not disappear entirelyAt the academic report of all academicians at the seventh academic annual meeting of the Chinese Academy of Sciences, Gao Fu, director of the Chinese Center for Disease Control and Prevention, also said that the new crown epidemic is becoming more and more influenza-like, and it may be necessary to coexist peacefully with the virus and slowly Xi such a life.
In view of this situation, first of all, the new crown is very different from the flu, whether it is in terms of infectiousness or the degree of harm to the body, ** and the drugs to prevent the new crown still have great clinical value. The existing methods of prevention and prevention are insufficient, the adverse reactions are high, and the contraindications of drug use are more prominent, and a broad-spectrum, efficient and safe anti-coronary drug is urgently needed. At that time, when the project was established, I actually thought very clearly, YKYY017 nebulized inhaler is a broad-spectrum, efficient and safe anti-crown drug, not limited to the new crown, but also effective against various coronaviruses and even influenza, which is the focus of our consideration. Song Gengshen said that drug research and development should not only look at the present, but also focus on the future, and if you want to lead, you must have a forward-looking layout and a clear judgment on the trend. ”
In his eyes, the investment in research and development of real gold and the control of product quality will become a weapon to break all doubts. "Pharmaceuticals are for the people's health, and we should have high quality and strict requirements for treating diseases and saving people, and I have always emphasized in the company that we must overcome various difficulties, continue to develop good drugs that the people can afford, and promote the high-quality development of the pharmaceutical and health industry. Yu Weishi said.
Yu Weishi led Yuekang to soar into 22 years. In the 22 years of development, the blueprint for "Centennial Yuekang" has gradually become clear: to build an innovation-led biomedical enterprise;Deepen the integrated production system of the whole industry chain of raw materials, excipients and preparations, and build a leading enterprise in the whole industry chainUnswervingly take the international route and practice the strategy of going overseas.