Chasing Dreams in Medicine Valley | Min Wang Irwin of Reistone Biopharma: China's power to explore the global autoimmune diseases


Reistone, led by Min Wang Irwin, has been a new force to Zhangjiang Biopharma Base in recent years.

Relying on Hengrui and targeting at globalization, Min Wang Irwin has set up a complete team with global clinical development experience and registration capability within more than a year, and has accurately positioned the drug R & D and promotion in the field of autoimmune diseases; while planning the short-term project for advancement. She is also looking for excellent pre-clinical “leaders”around the world for long-term planning. Min Wang Irwin, who left the impression of " being gentle and elegant" in the interview, has the temperament of a “drug-hunter” - keen insight, deep planning, down-to-earth and daring to think and act.

Formal establishment of Reistone R & D Center

Photos for speech delivered by Ms. Min Wang Irwin & opening ceremony

On June 17, Reistone held a small opening ceremony & academic forum at the R & D headquarter in Zhangjiang. When Min Wang Irwin delivered the speech at the scene, Dr. Zhang Lianshan, senior deputy general manager & global R & D president of Hengrui Pharmaceutical repeatedly said that, Hengrui Pharmaceutical gave high expectations to the establishment of Reistone. Facing this entrustment of “great responsibility”, Min Wang Irwin solemnly invited the members of the start-up team to introduce them one by one.

Cao Haifeng, Wu Xiaodong, Lucas M Pilipski, Huang Qian, and Wu Yihan from left to right as shown in the above picture

Core team members of Reistone

Wu Yihan, chief medical officer, received his Bachelor of Medicine and Doctorate of Medicine degree from Aberdeen University, UK. He once worked in the UK headquarters of GlaxoSmithKline, with rich experience in the approval of IND and NDA in China and other countries;
Cao Haifeng, vice president in charge of registration and external affairs, once served as the head of the registration department at GlaxoSmithKline China and Boehringer Ingelheim China. Under his leadership, more than 20 products were approved in the fields of tumor, nerve, infection, skin, diabetes, cardiovascular, immunity, respiration and vaccine;

Lucas M Pilipski, US office and international clinical operation head & executive director, once was the clinical study director of Shire Pharmaceutical Contracts Limited;

Huang Qian, China clinical operation head & executive director, She has worked in MSD R&D as head of clinical project management and prior to that she served in Roche as global studies leader;

Dr. Wu Xiaodong, business development director, has many years of working experience in North America. He once worked in Johnson & Johnson and Qilu Pharmaceutical, and is also a well-known business development expert in the circle.

Min Wang Irwin thinks, the core value of Reistone Biopharma is to build a Chinese team with global clinical development strength. On the basis of such concept, Reistone Biopharma attracted a group of excellent partners.

As introduced by Min Wang Irwin in the interview, as a global-oriented R & D enterprise, Reistone Biopharma has built the teams in Shanghai, Beijing, and Boston of the United States. Reistone team has been expanded to 62 members within just 1 year. The team is constantly expanding and growing with the orderly advancement of business.

Perfect transition from VP to CEO

Min Wang Irwin said that, she had a special fate with Zhangjiang. In 2005, as vice president of clinical development and medical affairs of Bayer in Mainland China and Hong Kong, she returned to China. Although her office was located in Beijing, she needed to travel to Shanghai for business frequently. Later, she was hired to work in GSK, which started her journey in Zhangjiang.

“On January 1, 2013, after working 8 years for Beijing Bayer in China, I was invited by GSK to serve as the vice president of medical development in China branch in Zhangjiang. I have always been looking forward to Zhangjiang Medicine Valley for communicating with and learning from numerous large international pharmaceutical companies and small biological companies. The four-year working journey here has established a deep emotional connection between Zhangjiang and me.”

Afterwards, when serving as a senior executive in the multinational enterprise, including as the head of clinical development of Takeda in Asia, she was always thinking about how to bring local projects to other countries and become a global pioneer based in China by combining her more than 25 years of experience in global and Chinese clinical development.

Later, she joined Qiming Venture Capital as an investment partner. This short working experience gave her a deeper understanding of the industry development and business model, and also made her have a strong thought to “build an innovative pharmaceutical company with global competitiveness in China but dominated by a team composed of local great talents by combining the existing accumulative experience in clinical projects.”

When being asked why she cooperated with Hengrui, Min Wang Irwin said that, “I admire the perseverance of Hengrui in new drug innovation. It is precisely because of its strategic layout and perseverance that Hengrui has begun to harvest the innovative outcome. The firmness and courage of the transformation from generic drugs to innovative drugs in China come not only from the wisdom of the decision makers, but from the strength of the team.”

In the interview, as an entrepreneur with a clinical background, Min Wang Irwin laughed and appreciated for her previous experience in project management at the grassroots level and in negotiation of clinical cooperation with private clinics overseas, and her understanding of domestic medical system for 15 years after returning to China. All of these made the project have experience to follow when it encountered difficultiy in each step.What impressed her deeply was, when she and her team held a communication meeting with FDA, “although everyone was a little nervous at first, but not afraid at all, with the deepening of communication, the discussion went smoothly, because we promoted the trials in strict accordance with international standards.”

The founder Min Wang Irwin and her team were in FDA

Global vision of Chinese start-up pharmaceutical companies

On October 18, 2018, Reistone Biopharma Company Limited announced that, FDA approved its application for the ulcerative colitis phase II clinical trial of its SHR0302, a novel and small molecule JAK1 inhibitor. SHR0302 was licensed by the investor of Reistone, Jiangsu Hengrui Pharmaceutical Co., Ltd. (“Hengrui”). Afterwards, US FDA approved the application for Crohn's disease phase II clinical study on SHR0302. At the same time, these two applications were approved for clinical trials in China, Poland and Ukraine successively. This Sino-US-European international multi-center clinical studies had thus entered the global launch and patients enrollment phase.

Commitment to be a pioneer in the R & D of autoimmune diseases

With regard to the R & D orientation of this start-up company Reistone, Min Wang Irwin said that, “we hope to make deeper and broader R & D of autoimmune diseases.”

“In fact, there is a large number of patients with autoimmune diseases throughout the world. These diseases can survive for a long period, and patients need to take medicine for life once being diagnosed. If we can continue to develop more valuable new indications through clinical trials of high quality in this field, more patients will be accessible and benefited.”

For Min Wang Irwin with clinical background, the original intention of her thinking was all about patients.

Ulcerative colitis (UC) and Crohn's disease (CD) are chronic progressive, inflammatory and autoimmune diseases that have impacts on gastrointestinal system, characterized by alternation of chronic recurrence and remission, which severely affects the quality of life of patients. The incidence of IBD in the United States and Europe is generally high. According to the data from CDC, the incidence rates was as high as 240 per 100,000 for UC and 200 per 100,000 for UC, with the annual new incidence rate about 6-8%. The incidence in Asia is relatively low, and in China, the incidence rates was as high as 11.6 per 100,000 for UC, and lower for CD. However, according to the new data, the incidence of IBD in China has annually increased in the past 20 years, and the new incidence rate is about 2.05 per 100,000 for UC and 1.09 per 100,000 for CD.The number of new cases is equivalent with that in the United States.

At present, as there is no cure for the disease, the therapeutic principle of ulcerative colitis and Crohn’s disease is to block the disease progression, induce and maintain the disease remission, and to avoid surgery and disease complications. The anti-TNFα antibody, a novel immunosuppressant developed ten years ago, has a great influence on the treatment of inflammatory bowel disease. However, it has been found that the long-term use of these biologics in the treatment may cause lack of response caused by immunogenicity in some patients. Therefore, it may be necessary to increase the dosage and / or reduce the dosing interval for the patients. In addition, most patients cannot afford these expensive biologics. The small molecule drug is convenient for administration, suitable for long-term treatment of the patients.

During the interview, while hearing Mr. Medicine Valley say that some clinical experts in hospitals regard the Crohn's disease as a rare disease, Min Irwin began to analyze carefully that, “rare diseases have not been clearly defined in China. By referring to the provisions in the United States, we know that a disease with less than 200,000 patients can be defined as a rare disease. However, Crohn's disease has not been covered in the list of rare diseases from National Health Commission of the People’s Republic of China. Perhaps it is difficult to judge the symptoms diagnosed in domestic hospitals, and there is no accurate data to support the provision.”

Afterwards, Min Wang Irwin also stated that, she would investigate the number of patients in China through clinical practice, and also encouraged Mr. Medicine Valley to appeal for attention from everyone from the perspective of media.

“At present, three products are under clinical trials, and it is expected that good results will be shared with you by the end of next year.”

Min Irwin proudly said when it came to the progress of pipeline under investigation of the company.

Reistone is committed to the corporate globalization strategy, but faces huge challenges in this regard: first, there are very few top experts in globalization; second, it is difficult to enroll patients. These are the problems that must be resolved on the way to globalization. Min Irwin spoke out bluntly in the interview.

There are opportunities and challenges, but Reistone firmly believes that innovation is endless, and there is a quick way to achieve the goal.Never forget the original intention, and forge ahead!

Date of issue:2019-08-17 13:14
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