“Now we have 22 product pipelines, including 18 products in the clinical development stage, 12 products in the post-clinical development stage, and five products approved in the United States.” For an innovative drug that has only been established for 7 years For enterprises, this can be regarded as a remarkable achievement. It is precisely because of this that Zai Lab established the “Zai Lab Model” in the industry.
Recently, during the “Post-medical Insurance Era, Ovarian Cancer Diagnosis and Treatment Ecosystem Full Management Summit Forum”, Dr. Xu Ning, Executive Vice President and Head of Clinical Operations of Zai Lab, In an interview with a reporter from the News (www.thepaper.cn), it was stated that in terms of choosing a track, “we are patient-centric and patient-oriented for product development. Many companies may focus on a certain area, but we are not just doing product development. For cancer, we also have anti-infection, autoimmunity, small molecules, macromolecules, medicines and equipment.”
Xu Ning added that Zai Lab is in When setting up the pipeline, it focused on the three major therapeutic areas of tumors, autoimmune diseases and anti-infection. The focus was first to meet new therapeutic areas with unmet clinical needs. “Therefore, whether we develop or introduce independently, we are looking for a product that matches our ideas.”
talked about “License in” ( Authorized introduction) model, Xu Ning believes that this model should be regarded as “open innovation.” “For example, the largest pharmaceutical company has hundreds or thousands of scientists at best, but these hundreds or thousands of scientists cannot be compared with the millions of scientists in the world. They are all doing research, and major pharmaceutical companies look for some promising results and introduce them. This is how this concept came about.”
He also emphasized, “License in” It is by no means the same as “buy, buy, buy”. Xu Ning told reporters that in terms of independent innovation, “we are also actively doing it internally.” Previously, in October 2015, Zai Lab established a R&D center in Shanghai; in May 2017, the global R&D headquarters was in Zhangjiang, Shanghai. Completion; In addition, Zai Lab also has a R&D center in the San Francisco Bay Area for early detection and clinical development. In the first half of 2020, it opened a 20,000-square-foot R&D base in Menlo Park, California. Xu Ning believes that these are all adding weight to Zai Lab’s independent innovation, and the goal is to have 1-2 global new drug clinical trial applications (IND) each year in the future.
Liang Yi, Chief Commercial Officer of Zai Lab and President of Greater China Region, told the reporter of News (www.thepaper.cn),Said that now should be the best time, no matter from policy, capital to talents, all aspects are very good. “He said with emotion, we can see that many innovative companies have succeeded in IPOs in Hong Kong. “This is unprecedented. I have worked in the pharmaceutical industry for more than 20 years and this is the first time I have seen such a prosperous scene.” “
Liang Yi believes that the globalization of Chinese pharmaceutical companies will be one of the important issues in the future if it is to benchmark the United States. In addition, he also mentioned, “From the basic In terms of research and development, there is still a gap between our independent research and development compared with the United States. This is true. Most innovative drugs in the world are mostly from European and American companies. We have to recognize the gap and have a long way to go. “
From a national level, Liang Yi believes that the investment in basic science is still a very important point. “It requires a lot of top-level design, and the enterprise is only a part of it. , To improve the national biomedical technology research and development strength requires comprehensive consideration, and all aspects need to be advanced. ”
Zai Lab is headquartered in Shanghai and was established in March 2014. Three years later, in September 2017, the company was listed on the Nasdaq in the United States. It was listed on the Hong Kong Stock Exchange for the second time in September 2020. The company stated on its official website: For global biopharmaceutical companies seeking to enter the Chinese market and find long-term strategic partners in international clinical development, Zai Lab relies on a series of successful cooperation cases. Become one of the most trusted partners in the industry.
Zai Lab’s goal for the next three years is Products are approved and commercially launched, we will join hands with more partners to expand global business, and continue to promote the development of internal pipelines with global intellectual property rights.
It is worth mentioning Yes, Dr. Du Ying, the founder, chairman and CEO of Zai Lab, is a leader in China’s bio-industry. She started her career at Pfizer in 1994 and founded Hutchison Whampoa Pharmaceuticals (Shanghai) Co., Ltd. in 2002 Company. In 2012, Du Ying joined the Sequoia Capital China Fund as the managing director in charge of investment in the healthcare industry. Driven by the passion for new drug research and development, Du Ying returned to the status of an entrepreneur and founded Zai Lab in 2014 .
Textbook-level cooperation model
Zai Lab’s official website shows that up to now, three of the company’s products have been approved for listing in China.
In December 2019, the National Medical Products Administration (NMPA) of China approved the PARP (polyadenosine diphosphate-ribose polymerase) inhibitor Zele® (Niraparib) as a A new drug application for maintenance treatment of adult patients with recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with complete or partial remission of platinum-containing chemotherapy. In September 2020, the NMPA approved a supplementary new drug listing application for Zele® for the maintenance treatment of adult patients with advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer after first-line platinum-containing chemotherapy has achieved complete remission or partial remission.
In May 2020, NMPA approved the marketing application of Epdun®, a portable device for tumor electric field therapy (TTFields), for the treatment of new diagnosis in combination with temozolomide The treatment of patients with glioblastoma, and as a monotherapy for the treatment of patients with relapsed glioblastoma.
In March 2021, the tyrosine kinase switch control inhibitor Qingle® was approved by the National Medical Products Administration for the treatment of Adult patients with advanced gastrointestinal stromal tumor (GIST) treated with 3 or more kinase inhibitors.
The above three products are all jointly developed with partners. Regarding how to view this model, Xu Ning, who is in charge of clinical operations, told reporters that from a clinical perspective, there are several laws.
First, when choosing a partner, the first thing they look at is not money, but to find a partner who can help develop together where development is impossible, and finally shared. “So in the end he must look at success. For this success, he must look at many factors when choosing a partner. First, he must look at your company, what kind of people are you, and your scientific understanding of this product When it comes to development strategy, is there such a capability and strategic thinking.”
Second, do you have previous successful experience. “You have made a successful product before and you have launched the product to the market. He thinks that you have successful cooperation experience. This is also very important.”
Third, In the cooperation, do the two parties have a common language, common scientific thinking, and way of working? “Do you have the ability to have a good cooperation with companies with different characteristics? I think this is very important in the entire cooperation.”
Xu Ning believes, Generally speaking, Zai Lab introduced productsMore depends on the team’s past experience. “And now is a virtuous circle. We push products to the market in accordance with our commitments and even exceed the expectations of our partners. This will increase the confidence of our partners and attract more partners, so we are now equivalent to Their preferred partner in China.”
Liang Yi added, “For example, our cooperation with an Israeli company, the chairman of Novocure said that his cooperation with us is textbook-level Yes, it fits his imagination very much, and what he said is exactly the same as what he did.”
Prior to September 2018, Zai Lab and Novocure announced a strategy In cooperation and an exclusive commercial license agreement, Zai Lab will develop and promote the listing of Novocure’s tumor electric field therapy in Greater China, and cooperate with Novocure to develop products on a global scale, namely the aforementioned Epdon®, the technology Originated in Israel.
ZeLe® is also a model. Zai Lab successfully commercialized Zele® in just 2 years.
Of course, the “License in” model is not the whole story. Zai Lab adopts a two-wheel drive development model with independent innovation and external introduction in parallel. “We have been doing this for several years. We first built a R&D laboratory in Shanghai, and now we also have our R&D center in the United States. We are actually actively doing it internally, and we will truly innovate independently.” Xu Ning said The news reporter said so.
“As long as it can benefit patients, we must do it”
Zi Lab’s first product launched in China, Zele®, is mainly aimed at For patients with ovarian cancer, the main results of the clinical Phase III PRIME study of Zele for maintenance treatment of first-line ovarian cancer carried out by Zai Lab in China are expected to be announced within this year. In addition, it will continue to explore other indications of Zele and other drugs. Opportunities for joint use.
Liang Yi mentioned, “ZeLe® has not missed any opportunity to help patients. After approval, we soon achieved national coverage. Second, the country started When preparing to enter the medical insurance negotiation, we prepared all the data. We also actively cooperated with the government to reduce the price with the utmost sincerity and enter the national medical insurance catalog. Some companies are not willing to do so much. We do not. We are also willing to cut prices to benefit patients.”
But Liang Yi believes that these are far from enough to truly expand the availability of medicines. “As long as it can benefit patients, we must do it. “He emphasized that the implementation of medical insurance varies from place to place. Even if the medical insurance is insured, no medicine will go to the pharmacy or hospital overnight.
just before. On May 10, the National Medical Insurance Administration and the National Health Commission jointly announced the “Guiding Opinions on Establishing and Improving the “Dual Channel” Management Mechanism for Drugs in National Medical Insurance Negotiations” (hereinafter referred to as “Guiding Opinions”). Retail pharmacies are included in the coverage of medical insurance drugs, and they implement a unified payment policy with medical institutions. After the negotiated drugs enter the medical insurance catalog, medical insurance insured patients can obtain them through two channels, designated medical institutions and designated retail pharmacies, to meet the needs of negotiated drugs. Reasonable demand for supply guarantee, clinical use, etc.
This is the first time that the hospital + pharmacy “dual channel” model has been officially promoted at the national level. Liang Yi said Said, “If this city encourages reimbursement in pharmacies, then we will go to pharmacies to release and distribute the goods. If some places are indeed single-channel, then we will also actively cooperate with the government to put medicines in hospitals. There is no set way, but as long as there is an opening that can benefit the patient, we will do it. Whether single-channel or dual-channel, it is ultimately convenient for patients to get the medicine easily and get reimbursed. “
In addition to entering the medical insurance catalog, Zai Lab also promotes commercial insurance cooperation from the perspective of enterprises. During the aforementioned forum, Zai Lab joined forces with ZhongAn Insurance and Magnesium Health , Released the country’s first female care insurance program for ovarian cancer. It is understood that the public welfare insurance program will focus on outpatient and hospitalization medical expenses, genetic testing, special drug protection, and serious adverse reactions after medication. It is expected to be Officially launched in July of this year, both healthy and sick women who meet the conditions can be insured and payable. The total insured amount for healthy people will be as high as 54,000 yuan after enrollment, and eligible women with illness will enjoy up to 25,200 yuan after enrollment. Liang Yi said, “It is impossible to negotiate all medicines in national negotiations. Accessibility is a problem that needs to be resolved in China. If a drug is not included in the National Medical Insurance List, how can we help patients? Commercial insurance is now a very good tool. “
He mentioned that the enthusiasm of insurance companies is much higher than that of a few years ago. , Financial company cooperation. Liang Yi believes that commercial insurance for high-priced tumor products has now become a “standard configuration.”
It is worth mentioning that the primary level cancer diagnosis and treatment capabilities are also within the scope of Zai Lab. Professor Qin Shukui, vice chairman of the Chinese Society of Clinical Oncology (CSCO) and Professor Qin Shukui from the Cancer Center of Nanjing Jinling Hospital, pointed out at the aforementioned forum, “In clinical oncology treatment, including ovarian cancer, my country still faces a large base of tumor patients in primary hospitals. The serious situation of poor treatment effect and poor prognosis. Especially in the construction of oncology specialties and standardization of diagnosis and treatment, the uneven diagnosis and treatment level of primary tumors and the lack of awareness of standardization of the whole process have become important to effectively improve the five-year survival rate of malignant tumors such as ovarian cancer in my country. Bottleneck.”
In this forum, the company announced the launch of the “Spark Plan Sailing Action—”New Life, Happy Future” Clinical Tumor Decision-Making and Standardization Project”. The project, led by Qin Shukui, aims to improve the professional academic ability of gynecological oncologists in urban and grassroots hospitals, as well as the level of ovarian cancer diagnosis and treatment, and service capabilities through large-scale training programs, and to build the capacity of primary-level oncology specialists through large-scale public welfare projects to promote the standardization of ovarian cancer in my country The establishment of a diagnosis and treatment system.
The project plans to help 2,000 hospitals across the country improve their ability to regulate cancer diagnosis and treatment by 2023, promote hierarchical diagnosis and treatment, and allow more primary medical institutions to participate in the standardization of ovarian cancer diagnosis and treatment. In the project, a consensus on diagnosis and treatment was formed.
Liang Yi believes that speeding up the launch of new drugs, entering medical insurance, and actively expanding commercial insurance are still not enough to narrow the five-year cancer survival gap between China and the United States. “After entering the medical insurance, another problem arises. Because the price is no longer a problem, many doctors can use it, and it is no longer available for very high-end hospitals.” What is the level of diagnosis and treatment of the grassroots doctors? Liang Yi thinks this is the difference between China and developed countries.
“We are not so narrow-minded. We only introduce our products. We want to improve the overall level of Chinese doctors serving patients and contribute to the entire Healthy China 2030 plan. “
Liang Yi believes that the participation of innovative pharmaceutical companies in the construction of a healthy China is a long-term work to be carried out. As the Chinese pharmaceutical ecosystem enters the 2.0 era, A sustainable pharmaceutical innovation ecosystem is underway. “As a local innovative pharmaceutical company, we also hope to continue to innovate and explore in the field of ovarian cancer, truly empower the grassroots, the industry, and the patients, unite all the forces that can be united, build and continue to promote The development of the ecosystem will ultimately achieve the goal of increasing the five-year survival rate of ovarian cancer in my country.”