Outline

Xiling Lab Co., Ltd. (hereinafter referred to as "Xiling Lab") is a China-US joint venture based in CDHT and specialized in the R&D of innovative drugs. It was founded by Dr. Huang Jinkun, an expert in pharmaceutical preparation technology and Dr. Xie Dejian, an expert in the R&D of innovative drugs in 2016. Now, it is located in Tianfu Life Science Park. Based on the concept of "Chinese Feelings, Global Vision", Xiling Lab has built a technological platform for the intelligent production of drugs and been committed to the development of high-end generic drugs and differentiated innovative drugs. In today's personal interview, let's talk with Dr. Huang Jinkun, co-founder and CEO of Xiling Lab about the company's business layout and the current situation of the R&D of generic drugs in China.

Profile:

 

Dr. Huang Jinkun is the co-founder and CEO of Xiling Lab, an expert in research and application of catalytic technology and a leading figure in the process development and industrial production of chemical drugs. He was engaged in research and development of innovative drugs for near 11 years in Amgen, the world's largest biopharmaceutical company. From 2012 to 2016, he was Chief Scientific Operating Officer of Hengrui Medicine Chengdu R&D Center (Chengdu Suncadia Medicine Co., Ltd.), fully responsible for the process and R&D of generic drugs. He has successively led or participated in the development and production of chemical process and preparations of more than 50 drugs and accumulated rich practical experience in pharmaceutical preparation technology.

 

Rich experience led to the establishment of Xiling Lab

Dr. Huang Jinkun received the bachelor's and master's degrees in science from Wuhan University. In early 1996, he studied in the University of New Orleans for a PhD in chemistry. After graduation, he joined DECODE GENETICS (acquired by Amgen in 2012) and won several NIH SBIR programs as the principal investigator (PI). [u1] Looking back, Dr. Huang Jinkun said frankly that he had made many difficult decisions in his life. In 2002, he resigned from DECODE GENETICS and then worked as a postdoctoral researcher at Harvard University, and joined the research group of ELIAS JAMES COREY (a great master in organic synthetic chemistry) for further study. Later, he joined the world's renowned biopharmaceutical company Amgen for R&D of micromolecular innovative drugs. In 2012, when still knowing little about the domestic employment environment and pharmaceutical industry, he gave up the favorable working environment of Amgen, returned to China and joined Jiangsu Hengrui Medicine to facilitate the domestic pharmaceutical R&D. In August 2016, Dr. Huang Jinkun and Dr. Xie Dejian, then General Manager of Chengdu Wisdom Technology Co., Ltd, founded Xiling Lab Co., Ltd. which is committed to high-end intelligent production, original research and innovation.

 

The areas involved in the modern pharmaceutical industry, including target validation, drug discovery, safe efficacy assessment, clinic research as well as production and quality control, cover the combination of many disciplines. Dr. Huang Jinkun has been active in the field of chemical pharmacy throughout his career. As he had a deeper understanding of the current situation of domestic and foreign pharmaceutical industries, he found that there were few high-end enterprises specialized in CMC (Chemistry, Manufacturing and Controls) in China. The CMC R&D of micromolecular drugs is taken as an example. From synthesis of BPC, quality research, preparations development, pilot test and process verification to how to scale up production, the whole process also involves safe production, quality assurance, environmental protection and engineering technology application, so pharmacy is a huge and systematic project.

 

As an expert in CMC, Dr. Huang Jinkun would like to make unique contributions to China's pharmaceutical industry based on his long-time experience and expertise. Coincidentally, he happened to hold the same view with Dr. Xie Dejian, then General Manager of Chengdu Wisdom Technology Co., Ltd, and thus Xiling Lab was born.

△ Xiling Lab

 

With the catalytic technology as its support, Xiling Lab is a small yet well-equipped team. It has a complete layout in R&D of BPC, quality control and quality assurance. At present, Xiling Lab is specialized in the following three areas:

 

》Catalytic technology and application platform

 

The modern catalytic technology is widely used in R&D and production of pharmaceutical products. Xiling Lab is committed to building a key technology platform with chemistry/biological catalysis as the core, and also developing the production process which is safe, efficient, green and low in cost. Xiling Lab has applied for 9 patents on new catalytic and process technologies and their applications since its establishments. Among them, four patents have been transferred to cooperative pharmaceutical enterprises for the production of intermediates as well as API declaration and production. Meanwhile, Xiling Lab will catalyze the technical platform into a special tool for innovative drugs development.

 

》High-End & Characteristic Generic Drug

 

The development of high-end generic drugs is seen as the medium- and long-term development goal of Xiling Lab. Under the orientation, Xiling Lab will fully bring the catalytic technology and the experience of the pharmaceutical team into play, so as to independently or collaboratively develop the medical intermediates, active pharmaceutical ingredients (APIs) and preparation products. At present, by adopting the marketing authorization holder (MAH) system to cooperate with pharmaceutical enterprises at home and abroad, Xiling Lab has placed emphasis on the development of characteristic APIs and preparations for specialized diseases. Many products are hopeful to be the pioneering generic drugs domestically, and be sold to markets of developing regions like Europe, America and Japan.

 

》 Differentiated Innovative Drug

 

Xiling Lab has joined hands with American biotechnology company ConSynance in New York to develop the Category 1.1 innovative small-molecule drug, that is CSTI-300 for the cure of irritable bowel syndrome (IBS). CSTI-300 is a world-leading and global-pioneering drug, which will apply for the American FDA clinical approval letter and be launched for the first phase of clinic trial in 2019. In the meantime, the pipelines for innovative drugs development are being increased gradually.

Radical Efforts Shall Be Paid into the Research and Development of Domestic Generic Drugs

At the present stage, China is holding a large market share (about 85%) of generic drugs. People show their concern over generic drugs in two aspects: i. whether they are safe and effective as the original drugs; ii. whether they can offer a more competitive price than the original drugs. At the outset, the state encouraged the development of generic drugs for reducing the expenditure of both the government and patients on the premise of ensuring the drug quality. So, if generic drugs triumph over the original one on the aforementioned dimensions, patients will be liberated from the restriction on expensive imported drugs, but replace them with the domestic products. Disappointingly, Dr. Huang Jinkun indicated that considering the status quo of pharmaceuticals industry at home, most domestic generic drugs cannot rival the original drugs on the performance and index of various aspects (the original drugs still hold a proportion of 65% and more). In this sense, there is room for domestic generic drugs to enhance the trust of doctors and patients.

△ Work Environment in Xiling Lab

 

"Nowadays, capital is more intended to invest into the innovative drugs especially the innovative biological medicines, which is undoubtedly favorable to boosting the R&D of innovative drugs. However, challenged by foreign giants of scientific research, it is still arduous to develop innovative drugs that are trustworthy in overseas markets. Also, China's pharmaceutical industry shall ineluctably confront this and enter into the international market. It is of the highest priority for the industry to make generic drugs more accessible and domestic drugs replaceable with imported ones at least over a period of time," Dr. Huang Jinkun introduced.

 

Dr. Huang Jinkun also pointed out that at present, no matter in the field of generic drugs or in other production fields restrained by foreign technological barriers, domestic enterprises essentially lack the spirit of "tracing the source" as a whole. Although the drug quality is closely related to the foundation of national economy and people's livelihood, numerous enterprises of generic drugs in the pharmaceutical sector only pursue the "appearance similarity" to the original drugs, but ignore the solid research foundation, resulting in the impossibility of understanding the R&D thought and production process from the source. Many original drugs were marketed in Europe and America in the 1980s and 1990s, and later entered the Chinese market. Nearly twenty years passed, but there were still very limited domestic enterprises that produced qualified generic drugs of the off-patent medicines and successfully got them marketed.

 

On how to change the status quo to replace imported drugs with domestic ones and lift domestic pharmaceutical industry out of the trap of generic drug R&D at root, as well as make breakthrough on the sustained drug release and drug delivery system, Dr. Huang Jinkun shared his opinions. The first is to cement the basic research and effective cooperation of diversified disciplines; the second is to strengthen the collaboration among universities, scientific research institutions and enterprises across the globe to commercialize new achievements; the third is to enhance the capital input and government policy support; and the last and most important is to create a sound business environment.

On the Context of Entrepreneurship of Biological Medicine in Chengdu

Despite that most imported original drugs enjoy more competitive quality over domestic generic drugs and monopolize a larger market share, it is not disappointing as Dr. Huang Jinkun perceived. It is optimistic that national policies have kept up the pace and the drug regulation system has been geared to international standards as the government advocates. Moreover, considering the personnel of innovation and entrepreneurship introduced into the biological medicine field and the financing environment in recent years, high-end returned overseas Chinese are making their contribution to advancing the biological medicine industry of China. Dr. Huang Jinkun, a member of the accomplished returned overseas Chinese, has expressed his affirmation on the tremendous opportunities in the development of domestic pharmaceuticals industry.

 

As an experienced "Chengdu drifter" for staying here for 7 years, he cannot help but express his affection for this city. "First of all, the government of Chengdu has rendered great support to the development of pharmaceutical industry and the introduction of high-caliber talents; next, institutions of higher education and superior medical research resources like Sichuan University, Chengdu University of TCM and West China Hospital of Sichuan University, as well as a batch of emerging innovative enterprises are gathering in Chengdu, a place gathering the most and best talents in Southwestern China; what's more, Chengdu's more "tranquil" environment compared with that in coastal regions is conducive to the devoted R&D; and the most essential is that there is a group of like-minded and industrious young professional team," Dr. Huang Jinkun said proudly.

△ The Team of Xiling Lab