The pioneer work has endured great hardships, and 14 years of struggle is only for the research and development of original new drugs. This is a painstaking exploration. All efforts are only made to promote the development of China's original medicine industry. This is a sort of simple and deep feeling, and it is only in return for the land where he was born and raised.

He is Lu Xianping, the president of Shenzhen Chipscreen Biosciences Co., Ltd. He has a hot heart with a gentle and courteous appearance. Dedicated to the very aim, he by no means regrets what he’s been doing. 

China's original anti-cancer drug successfully "breaks the ice"

In January 2015, Chipscreen Biosciences held a press conference in Shenzhen, announcing to the public that Chidamide, which was China's original anti-cancer new drug of independent intellectual property rights, was approved for global launch. This meant that China had its own original anti-cancer drug. China's drug research and development had gradually entered the stage of independent innovation from imitation at the same level as developed countries and even ahead of time.

This piece of news is like a blockbuster that explodes the anti-cancer drug market, causing widespread concern. There are many top scientists in the field of biopharmaceutical in the world, but there are few who can develop an original medicine in their lifetime. Who is Lu Xianping?

Lu Xianping, is a Ph.D. in molecular biology and oncobiology at Peking Union Medical College and a postdoctoral fellow in the Department of Pharmacology at the University of California. In 2001, with the idea of serving his motherland, he and another five returnees founded the company to engage in the research and development of original new drugs.

"Our idea is very simple, that is, to change the current situation of China's original medicine industry." Lu Xianping said that China had the largest number of pharmaceutical enterprises in the world, reaching more than 7,000, with the world's largest production capacity of formulations and the world's second largest production capacity of API drugs, but few enterprises had developed and produced original medicines.

In the global pharmaceutical industry, original new drug research and development is a high investment, high risk, long cycle but high return industry. Generally speaking, it is possible to discover a molecular structure from tens of thousands of compounds for new drug development. A new drug development cycle of 10 to 15 years requires more than 1 billion dollars in research and development costs. In this sense, the success rate is only one in ten thousand.                  However, because original new medicines are protected by patents, once they are launched in the market, they can monopolize the market and bring hundreds of millions of dollars in revenue to pharmaceutical companies every year.

Chidamide is an original new drug developed by Lu Xianping and his team after 12 years which mainly fights against lymphoma. At present, the combined treatment of lung cancer and breast cancer has entered the later stage of clinical trials. Chidamide is the world's first subtype selective histone deacetylase inhibitor. Precisely because of the selectivity of subtypes, Chidamide has a unique anti-tumor mechanism, such as activating the anti-tumor cellular immune function of patients.

At present, there are only three enterprises worldwide that produce similar drugs, two of which are in the United States with monthly treatment costs of 280,000 yuan and 140,000 yuan respectively. In contrast, the monthly fee in Chidamide is only about 20,000 RMB. In terms of drug usage, Chidamide uses oral administration which is more convenient, instead of intravenous injection used abroad.

Sang Guowei, the chief engineer of the national major new drug discovery technology and the academician of the Chinese Academy of Engineering, commented that "It filled in the gap in the treatment of peripheral T-cell tumors in our country and played an active exemplary role in the transformation and upgrading of the biomedical industry in our country." Chen Kaixian, the academician of the Chinese Academy of Sciences, believed that the emergence of Chidamide had enabled China to reach the international advanced level in this field and to lead some of them. "Such a development model has broken the difficult situation of China's economic transformation and made Chinese pharmaceutical enterprises to realize their dream of being from "imitation" to "creation"."

After ten years of sharpening the sword, Chipscreen Biosciences have already achieved fruitful results. At present, in addition to the production and marketing of Chidamide for the treatment of lymph cancer, Chiglitazar for the treatment of type II diabetes independently developed by the company has entered the phase III clinical trial, the Chiauranib for the treatment of solid tumor of cancer has entered the phase I clinical trial, and the drugs for rheumatoid arthritis are being developed. Chipscreen Biosciences has established several original new drug product lines in the fields of tumor, diabetes, immune diseases and so on, and has applied for 73 global invention patents for compounds, 45 of which have been authorized.

Chipscreen Biosciences team is good at "wirewalking": managing risks scientifically

Lu Xianping described the research and development of original new drugs as "wirewalking". "Prince Adili from Xinjiang could walk on a steel wire between two high mountains. This was a super high-risk behavior. Others would fall off as soon as they go up, but Adili knew how to control risks." he said.

"Chipscreen Biosciences is a surfer of original new drugs because we understand the whole genome expression, computer-aided structural design, and data mining based on informatics, thus obtaining strong predictive data. Even if our chances of success only increase by 50 %, it also means that our chances of patent medicine are twice as high as those of others, and we will spend far less money than others." Lu Xianping said that they had "burnt" less than 1 billion yuan so far.

Even so, it is still difficult to find the ideal molecular compound through screening. The workload is comparable to looking for a needle in a haystack. Lu Xianping uses the "funnel as big as heaven" as an analogy: 2,000 chemical molecules will form 36,000 data points for 18 target points, and for each target point we will carry out repeated experiments several times. To screen out a reliable data, 300,000 test points will be carried out. From an infinite mouth, through continuous trial and error, continuous tightening, one or two suitable compounds can be selected from them, and sometimes nothing will be obtained.

Faced with the risk of scientific research failure, Lu Xianping remains as optimistic and calm as ever, "Choosing to make an original medicine means that every day we try to make mistakes, and every mistake provides a new message, which leads us to a new direction, breaks through all difficulties and approaches the bottom of the funnel continuously, experiencing the excitement and surprise of dawn at first sight. This is the joy of scientific research."

Finding a "capital baton" is another challenge facing Chipscreen Biosciences. Although the company received a venture capital of 6 million dollars at the beginning of its establishment, it was undoubtedly a drop in the bucket for the huge amount of funds needed for original new drug research and development.

"The cycle of new drug research and development is long, the risk is big, coupled with the lack of financial data in the early stage, the listing is far from complete, and the company is facing great difficulties in financing." Lu Xianping said that in order to make blood for himself, the company decided in 2006 to grant patent authorization to its developing Chidamide abroad to help enterprises obtain financial support as soon as possible.

This is a helpless choice. Because if authorization can be granted after the drug research and development has entered the clinical stage, the negotiation spirit will greatly increase. However, if the authorization is carried out too early, the risk of drug research and development is still relatively high at this time, and the benefits that the authorized party can obtain will naturally be discounted. "But the actual situation at that time was that we must survive first." Lu Xianping said frankly.

As multinational corporations recognize core technologies and product development enters a stage of risk measurement, the investment value of Chipscreen Biosciences is gradually recognized. After six rounds of financing, the government's special funds for pharmaceutical research and development continue to "send carbon in the snow". Chipscreen Biosciences finally went through it. It is estimated that the company's sales will reach 500 million yuan in the next five years.

Dream of "Dr. Lu": promoting the original Chinese new drug "spring blooming"

When asked about the setbacks and difficulties in the past 14 years, Lu Xianping smiled faintly, "This was not a sentence or two that could be made clear." The hardships of starting a business and the longtime of scientific research were all expected things. Lu Xianping had been psychologically prepared for this, being cold-shouldered for 10 years, looking for funds and bumping into obstacles everywhere, all of which were irrelevant.

Around 2005, two of the five business partners left the company because of their treatment and family, which made him "feel the pressure he never had", but Lu Xianping wasn’t thrown into confusion. Li Zhibin, one of his friends recalled that at that time Lu Xianping often went to the bar to light a cigar, "seek inner peace amidst noise" and thought about countermeasures. He sat for half a day.

What Lu Xianping minds most is the soft environment of original new drugs in China. In 2007, the national drug administration put forward a completely new requirement for animal carcinogenicity tests on the phase II clinic new diabetes drug developed by the company, which meant greater cost investment. The drug market would be delayed by four to five years, and the fate of the enterprise "hung in the balance". Although the company had exhausted their methods and finally completed the experiment according to the requirements of the regulatory authorities, the cost was very huge.

"More than ten years ago, when I returned to China to start my own business, all the links in China were not fully prepared to welcome innovative medicines. What we first encountered was the restriction of immature medical policies and technical specifications at that time." Lu Xianping was deeply saddened by this. He often shares experiences in various forums of the pharmaceutical industry and calls for the establishment of a more sound management system, a more perfect venture capital mechanism and more adequate patent protection. Now this situation has been greatly improved.

In Lu Xianping's view, China has excellent scientists and a good pharmaceutical foundation, but imitation has replaced innovation. It can only seek very little profit through price competition. It is at the low end of the pharmaceutical industry chain. Only by exploring the establishment of a virtuous circle of new drug research and development ecology, can China's pharmaceutical industry's enthusiasm for innovation be ignited.

Coming all the way, I’ll stay true to my original intention. "My idea is very simple. I hope that I can use what I have learned in return for my native land to cure and save people through scientific wisdom, which is my greatest achievement. Lu Xianping said that he preferred to be called "Dr. Lu" instead of "President Lu". As a scientist, he enjoys the happiness of scientific research and sharing. The name of each new drug developed by the company starts with "Chi", which means China and the English name chipscreen.

The greatest regret of Dr. Lu is that he had no time to accompany his family. During his 14 years of starting up business in Shenzhen, he could only fly back to the United States to visit his wife and children at regular intervals. His office desk was full of photos of his family: wedding photos, standard photos of his eldest son, and photos of skiing with his two sons more than ten years ago. Lu Xianping said: "When I left, my younger son was only three and a half years old and my older son was eight years old. Now they are already taller than me."