Wang Xijuan, chairman of Kangchen Pharmaceutical Co., Ltd.: a female leader who adheres to the research and development of innovative drugs

Picture: Wang Xijuan, chairman of Kangchen pharmaceutical, in the winter of Beijing, if there is no strong wind, no haze, the sun pours into the whole city, beautiful and luxurious On the day of interview with Wang Xijuan, chairman of Kangchen Pharmaceutical (hereinafter referred to as "Kangchen"), we caught up with such good weather Wang Xijuan likes red With short hair, dark red jacket and wine red scarf, Wang Xijuan has been smiling for several hours in an exclusive interview with E medicine manager After leading the enterprise through ups and downs, Wang Xijuan, now at this age, will properly control and interpret the red color: dazzling but not dazzling, warm but not publicity This year is the first year when Kangchen marketing puts forward "double first" (brand first, sales first) Sulin (hemagglutinase of Agkistrodon acutus for injection), a kind of new drug with ten years' hard work, has been paid more and more attention and favored by the market after five years' market baptism, and has gained a good sales momentum, and has become a famous brand innovation drug in this field in China Another anti-tumor new drug of Kangchen, Dior (noratrix hydrochloride for injection), has completed all phase I, II and III clinical studies after 15 years of long research and development, and formally applied for new drug certificate and production approval to CFDA Wang Xijuan is really fond of new drug certificates When asked about her "happiest time in life" and "favorite things", Wang Xijuan used "new drug certificate" as the answer The answer is both unexpected and reasonable Objectively speaking, China's innovative drug research and development really needs a dedicated female leader like Wang Xijuan She seems to be flexible, but in fact, she knows how to detour and relax, but the goal is always the established front The office buildings can be sold, but the products researched and developed can't be sold more than 10 years ago For Kangchen and Wang Xijuan, they started from scratch Moreover, Wang Xijuan is the only one of Kangchen's founding shareholders with a medical background After quitting her job as a doctor in the system, Wang Xijuan went to the sea to start the business of blood products and drug agents, and earned the first barrel of gold in her life It was in the process of drug agency that Wang Xijuan saw the huge gap between general medicine, generic medicine and innovative drugs of foreign companies "If I studied medicine, I might not dare to do research and development of new drugs in China at that time." Wang Xijuan said with a smile that she did not expect that it would be so difficult to develop innovative drugs in China In the early 1990s, snake venom hemagglutinase just entered China, and it is also the first snake venom hemagglutinase preparation imported from China In the domestic hemostatic market, this product is unique Wang Xijuan was also an agent of this product in Beijing However, the snake venom of this product comes from South America, which is difficult to source and costly After experimental study, Kangchen's researchers found that the venom of Agkistrodon acutus (commonly known as Agkistrodon acutus) in South China contained thrombin This discovery not only brings excitement and hope to Wang Xijuan and her R & D team, but also leads Wang Xijuan and her team on a journey of innovative drug R & D that she didn't even expect It can be said that the ignorant are fearless In 2000, Wang Xijuan, who had just embarked on the research and development of innovative drugs, bought all the property rights of the anti-tumor innovative drug Dior from a well-known scientific research institution of a university Dior is the first new antitumor drug designed and synthesized by three-dimensional structural characteristics of enzyme activity center in China After Kangchen took over, in the process of follow-up research and development, in addition to retaining all the advantages and features of the product, Kangchen also specially improved, optimized and upgraded Dior's synthesis process, established a more scientific and more industrialized set of synthesis process, and obtained the Chinese invention patent In 2002, Dior obtained the approval of clinical research A small company that had just been founded and was unknown dared to carry out the research and development of two first-class new drugs, which was rare in the whole pharmaceutical industry at that time Wang Xijuan confessed that the three characteristics of innovative drugs, namely "high risk, high investment and long cycle", were gradually realized in practice At the beginning of the company's establishment, Kangchen formulated the enterprise development strategy of "433", that is, "to cultivate product resources in 4 years, to effectively connect with the capital market in 3 years, and to build the enterprise brand in 3 years" But the reality is that only in the first stage of cultivating product resources, Kangchen has spent 10 years Wang Xijuan found that putting money into new drug research and development is like entering a bottomless hole At the beginning of 2005, when the third phase of Sulin clinical trial was just over, and Dior began to enter the second phase of clinical trial, the national silver root was tightened, and Kangchen encountered an unprecedented financial problem At this time, some enterprises offer a high price to buy Sulin and Dior But Wang Xijuan thought it over and over again, but she still couldn't bear it Because suling and Dior are like the two children she pulled up The contradictions and struggles in the mind at that time can be seen In the end, Wang Xijuan tried to get rid of all the people's opinions and persuaded her venture shareholders to sell Kangchen's own office building, Haohai building, to ensure the normal development of innovative drugs Even if we use today's perspective to look at Wang Xijuan and her shareholders' behavior at that time, it's really moving and admirable, not to mention that it happened 10 years ago Haohai building was sold for emergency at a price of less than 50 million yuan in that year, while the valuation of the building in 2011 was more than 200 million yuan This is the pressure, hardship and cost of innovative drug research and development Everything comes to him who waits Sulin has finally been successfully listed It is the first single component snake venom hemagglutinase drug in the world, as well as the first snake venom hemagglutinase preparation to complete the full sequence determination of all amino acids and the three-dimensional spatial structure determination at the same time Suling ushered in a new era of snake venom hemagglutinase single component After that, Dior completed all the clinical studies For the survival period of patients and the objective remission rate of tumor, Dior significantly exceeded the current clinical standard treatment Wang Xijuan made no secret that at that time, she was basically half focused on R & D and half focused on calculating money Kang Chen even had to pay tomorrow Today's account is not settled It was a common practice in Kangchen at that time to borrow east wall to pay west wall and borrow new debt to pay back old money However, in the clinical trials of new drugs, Wang Xijuan never thought of saving money, and never stingy Kangchen has a clear feature in new drug R & D, that is, it does not fight alone in every important stage of R & D, but chooses to cooperate with the best research institutions and top researchers in its field "Despite the high cost, the results are reliable and can stand the test." Wang Xijuan told e drug manager In order to support the listing of suling and Dior products, Kangchen's factory construction was not affected in the most difficult period of capital, and was completed as scheduled In order to ensure that once the new drug certificate and production approval documents are obtained, Wang Xijuan, like the second grandmother of Bai family in dazhaomen, is sealed up in Baicao hall, but she keeps all the technical workers until Baicao hall reopens Wang Juan, general manager of Kangchen production center, said that when the factory was completed and waiting for the new drug certificate, her main job was to ensure that the key employees remained It was an important job for Wang Juan to train his employees at that time The worker's bonus assessment is based on the results of the training examination For production SOP theoretical training and practical training, relevant managers shall form an on-site evaluation team to give scores to each practical operator After the training, the staff should be a teacher and explain it to other staff to strengthen their memory and understanding Wang Juan asked the employees to write the relevant documents of GMP certification over and over again She revised them word by word At last, all links and processes of GMP certification were familiar to the employees It was a natural thing to pass GMP certification once At the same time, Wang Juan also led the staff to maintain the normal operation of the machine, "because once the machine stops, it is very difficult to let it move again." Although no products were put into production, the machines in Kangchen's workshop roared and the glass windows were polished It was in that period of waiting for the new drug certificate that Kangchen laid a solid foundation in terms of production quality and safety Since it was put into operation in 2009, there has been no quality and safety accident in Kangchen factory and no quality problem in suling products in five years Those employees who were trained in the workshop have become the leaders of Kangchen factory management When suling received the new drug certificate and production approval issued by CFDA, although Wang Xijuan and the whole team had been looking forward to this moment for a long time, Kangchen did not hold any celebration activities, but continuously put into suling's production GMP certification Heaven rewards diligence, but diligence pays for itself Years of research and development consume Wang Xijuan's health Wang Xijuan was diagnosed with renal insufficiency shortly after she got the Sulin new drug certificate and put into production Doctors at Concord Hospital immediately asked Wang Xijuan to have a kidney puncture to diagnose the condition and make further treatment However, facing the critical stage of Sulin and Dior clinical trial, Wang Xijuan was unable to be hospitalized at ease She insisted on persuading her family members to take traditional Chinese medicine to relieve the pain and insist on normal work In the end, kidney transplantation was necessary Despite the success of suling, Wang Xijuan and her team did not meet the requirements Instead, they worked out enterprise standards from raw material quality control and inspection to the optimization of the quality monitoring system in the whole production process, focusing on the quality assurance of suling products Its goal is to ensure that suling becomes a benchmark product in the domestic pharmaceutical industry, and strive to make suling not only at home, but also in the world's snake venom hemagglutinase field at a leading level The idea is to choose the touchstone of the project Although Kangchen's current volume is not very large, it has been labeled as a new drug R & D enterprise While suling has been listed and Dior has completed the application, a new batch of R & D projects of Kangchen started a few years ago Among them, two of the three innovative drugs are first-class innovative drugs and have applied for PCT invention patents in 12 countries including expanding the United States Wang Xijuan believes that it is over 10 years that Kangchen has accumulated experiences and lessons in the research and development of innovative drugs with suling and Dior as carriers, which makes Kangchen more confident to touch new innovative drug projects Different from the past, Kangchen has a higher standard, a clearer and clearer positioning in the selection of innovative drug R & D projects There are essential differences between innovative drug R & D and generic drug R & D, which are reflected in the starting point, cycle, and the exploration and uncertainty of the whole process of R & D First of all, innovative drug research and development should be able to stand the loneliness, based on the present, but not focus on the present, but to establish a long-term goal Including the setting of milestones, we should not be eager for quick success and instant profits Secondly, in terms of R & D level and scientific and technological content, we should base ourselves on China, but look at the world We should not break away from the reality of China's pharmaceutical innovation and step up to the sky, nor do we want to be humble Instead, we should integrate the local reality of China's new drug research and development with the trend of international R & D technology, so as to achieve China's first-class and national level