Chidamide press conference on original new drugs, national 863 and special achievements of "major new drug discovery"

January 08,2015

Source: Shenzhen special zone daily

On January 27, 2015 (Tuesday) at 10:00, the press conference of Chidamide, the original new drugs, the country 863 and "major new drug creation" special results is held in the government press office (Civic Center B1039). Chen Kaixian, Deputy Director General of the National "Major New Drug Discovery" and member of the Chinese Academy of Sciences; Ma Jun, Director of Harbin Institute of Hematological Diseases and Director of the Steering Committee of the Chinese Association of Clinical Oncology; and Jiang Wenqi, Deputy Director of the Internal Medicine Department of the Asian Association of Clinical Oncology have presented the meeting.

The following is the transcript of the Conference:

Moderator: Qiu Xuan, Deputy Director of Shenzhen Science and Technology Innovation Committee.

Moderator: Let’s get the press conference started. Academician Chen Kaixian, Deputy Director Jiang Yuyang, distinguished guests, friends from the media, good morning. Today we are here to hold the press conference of original new drug country 863 and "major new drug creation" of the special results of Chidamide. Thank you for your visit.

Chidamide, the new drug, is a major achievement made by Shenzhen Chipscreen Biosciences Co., Ltd. after 12 years of investment of venture capital into the returnee team and experts. The research and development of this product not only contributed to the global research and development of new drugs, especially on genetics in the field of tumor treatment, but also played an exemplary role in the transformation and upgrading of China's biomedicine. Today, we gather here to release the results. We not only adhere to the innovation-driven development path and promote the spirit of innovation and entrepreneurship, but also hope that this important achievement will embody its value in safeguarding human health and play a role in promoting the development of bio-medicine in Shenzhen and even the whole country.

Let me introduce the leaders and guests attending the press conference today. They are:

Academician Chen Kaixian, vice president of national "major new drug creation" science and technology major special technology;

Mr. Jiang Yuyang, Deputy Director of the Standing Committee of Shenzhen People's Congress and Chairman of Shenzhen Science and Technology Association;

Professor Ma Jun, Director of Harbin Institute of Hematological Diseases and Director of the Steering Committee of the Chinese Association of Clinical Oncology, Deputy Director Member of Asian Clinical Oncology Society

Professor Jiang Wenqi, Head of Medical Department of Sun Yat-sen University, Cancer Center, Deputy Director of the Internal Medicine Department of the Asian Association of Clinical Oncology

Wang Xiana, Inspector of Shenzhen Food and Drug Administration;


Yue Xin, Director of Shenzhen Food and Drug Administration;

Tu Huan, Vice President of Shenzhen Research Institute of Peking University;

Dr. Lu Xianping, President and Chief Scientific Officer of Shenzhen Chipscreen Biosciences Co., Ltd. Today, those attended the press conference also include Shenzhen Science and Technology Innovation Committee, Shenzhen Health Planning Commission, Shenzhen Association for Science and Technology, Nanshan Association for Science and Technology, and friends of the news media.

Moderator: Chidamide is the fruit on the fertile soil for scientific and technological innovation in Shenzhen. Let us welcome Mr. Jiang Yuyang, Deputy Director of the Standing Committee of Shenzhen Municipal People's Congress and Chairman of Shenzhen Science and Technology Association, to give a speech.

Jiang Yuyang: Distinguished Academician Chen Kaixian, experts, friends from the news media, hello everyone!Today, we are very excited to participate in the result release conference of Chidamide, the first subtype selective histone deacetylase oral inhibitor in the world, held here by Chipscreen Biosciences. On behalf of our Municipal People's Congress, Association for Science and Technology and the city's medical researchers, I warmly congratulate Chipscreen Biosciences on their major scientific and technological achievements.

Chipscreen Biosciences is a leading enterprise in new drug research and development in China, which grew up in the biological incubator of Shenzhen hi-tech zone. Since its establishment in 2001, Chipscreen Biosciences has made important breakthroughs in many fields through the unremitting efforts of scientific teams and the support of a series of innovation policies of national/provincial/municipal governments, relying on the independent innovation mode of enterprise-oriented, market-oriented and combination of production, study and research. It has made remarkable achievements in the field of original new drug research and development worldwide. The major research result released today is the first oral drug in the world approved for the treatment of T-cell lymphoma, originally created by Chipscreen Biosciences. This great achievement has also won the support of the national major scientific and technological projects in the 10th, 11th and 12th five-year plans. It is currently conducting clinical research in the United States, Japan, Taiwan and other regions. It is the first chemical original medicine in our country to enter the global synchronous development.

After 13 years of persistence, Chipscreen Biosciences finally achieved success, relying on the spirit of bold exploration and innovation, the Shenzhen municipal government's innovative policies of supporting returnee teams, guiding venture capital and supporting key projects, as well as the innovative environment of Shenzhen's strategic emerging industries and future industries.

Shenzhen is a paradise for entrepreneurs, which has market advantages such as system, mechanism, technology, industry and management. It also has the government’s financial support to provide support for the rapid development of biotechnology. It hopes that more entrepreneurs will come to Shenzhen to live and work in peace and contentment and create miracles one after another.

Finally, I wish every new breakthrough in the researches made by Chipscreen Biosciences. I also thank the state Ministry of Science and Technology, Health Planning Commission, Guangdong Provincial Department of Science and Technology and other competent departments, all sectors of society and friends of the media for their concern and support for the company. I also thank everyone for their attention and help to Shenzhen's independent innovation for innovation-driven development. Thank you all.

Qiu Xuan: Thank you, Director Jiang. The press conference was also attended by representatives of medical institutions. Dean Cai of the second hospital also came to the scene today. Sang Guowei, who is the former Vice Chairman of the Standing Committee of the National People's Congress, and Chief Engineer of the state's major new drug creation technology and Academician of the Chinese Academy of Engineering, has been paying close attention to the research and development of new drugs. Academician Sang Guowei led a special national team of experts on new drugs to inspect Chipscreen Biosciences on the spot on August 29, 2014 and placed great hopes on enterprises. Academician Sang Guowei did not present today for work reasons. Next, I would like to invite Academician Chen Kaixian, Vice-chairman of the national "major new drug innovation" science and technology major special technology, to read out a congratulatory letter from Sang Guowei and make a speech.

Chen Kaixian: (reading out a congratulatory letter) I would like to extend my warm congratulations to Shenzhen Chipscreen Biosciences on the occasion of the approval of the completely independent and innovative drug "Chidamide" to be listed in the market. I would like to extend my sincere greetings to the comrades who have devoted years of painstaking efforts to this end.

Chidamide is the first subtype of selective histone deacetylase oral inhibitor, which belongs to a completely new mechanism of action-epigenetic regulation anti-cancer drugs, the first global synchronous development of original small molecule drugs in China, has won support from the 11th five-year plan "863" molecular design project and the national "major new drug creation" innovative drug incubation base, and has been selected as the "11th five-year plan" Ministry of Science and Technology's major scientific and technological achievements. Chidamide has filled the gap in the treatment of peripheral T-cell lymphoma in foreign countries, providing patients with new mechanism drugs that are effective, safe and affordable, and playing an active exemplary role in the transformation and upgrading of China's biomedical industry.

The CPC Central Committee and the State Council have always attached great importance to scientific and technological innovation. In the report of the 18th National Congress of the Communist Party of China, the "implementation of innovation-driven development strategy" was explicitly proposed. Beginning with the "863" plan, the country has clearly put forward the medium and long-term development goal of the strategic High-tech area including biomedicine. Through the organization of the "major new drug creation" , the major science and technology projects, to support a group of independent intellectual property rights, market competitiveness of new drug research and development and advanced level of technical platform construction work, to form a support for China's independent development of pharmaceutical medicine innovation technology system, and promote innovative drug research and industrialization, to provide high quality, inexpensive, safe and effective medicine for the prevention and treatment of major diseases in our country. It has greatly promoted the innovation ability and the transformation and development of the bio-pharmaceutical industry in China.

At present, China is in the transition period of economic development, the national medical health industry has entered a new era of all-round reform and rapid development. The Decision made at the 3rd Plenary Session of 18th CPC Central Committee and General Secretary Xi Jinping's important speech at the Academician's conference in 2014 have put forward the explicit request for the next step to implement the innovation-driven development strategy. We must firmly grasp the historical opportunity, further emancipate the mind, blaze new trails, bravely climb the peak, give full play to the main role of enterprise innovation, comprehensively improve the overall strength of our new drug creation, promote the rapid and healthy development of the pharmaceutical industry, meet the growing needs of the people, continuously improve our pharmaceutical research and pharmaceutical industry in the international status and influence.

It’s hoped to have more original new drugs developed successfully. I wish Shenzhen 

Chief engineer of the state's major new drug creation technology and the academician of the Chinese Academy of Engineering, Sang Guowei, January 23, 2015.

I would also like to take this opportunity to say a few words on behalf of the new drug project and on my own behalf.

Distinguished professors, distinguished President Lu Xianping, good morning. I am very happy to come to Shenzhen to attend the press conference on original new drugs, national "863" and "major new drug creation". First of all, I would like to express my warm congratulations on the great achievements made by Shenzhen Chipscreen Biosciences team and express my sincere thanks to all levels of governments and relevant organizations that support the cause of Chinese original new drugs.

I have seen many old friends and some new people. I am heartily pleased with the achievements and progress of our career. The first successful drug discovery based on epigenetics in China has made a number of original contributions in the field of new drug research and development. The successful launch of the Chidamide has marked a significant improvement in the core technology and capability of the integration of the molecular design, target research, safety evaluation, clinical development and the whole process of industrialization, which is a historic breakthrough in the pharmaceutical industry in China.

When Chipscreen Biosciences began to study this target in 2001, international research on epigenetic inheritance was still very early, and the scientific returnee team of Chipscreen Biosciences was at the forefront of the world. As the first subtype of selective histone deacetylase inhibitor to be successfully developed and launched in the world, Chidamide has made progress in its product development in keeping with the international advanced level and has led some of them. Today, the launching of Chidamide can not only fill the blank of T-cell lymphoma and epigenetic therapeutic drugs in our country, provide patients with innovative mechanism drugs with excellent efficiency, safety and affordable prices, but also provide valuable experience for the original new drug research and development work of Chinese local pharmaceutical enterprises under the existing environment in China. It also lays a foundation for the launching of original new drugs with global intellectual property protection in the follow-up series of the company, and will eventually make important contributions to the development of the biomedical industry and people's health.

The original innovation work has been completed in a small and medium-sized enterprise like Chipscreen Biosciences. As a member of the national expert Committee on major new drug creation, we are very concerned about the successful model of Chipscreen Biosciences. Looking back, the successful research and development of Chidamide is a beneficial exploration that is supported by the national innovation policy and invested by venture capital into the scientific team of returnees in collaboration with national clinical experts for collaborative innovation. Such a development model has broken the difficult situation of China's economic transformation and made the dream of changing from "imitation" to "creation" of Chinese pharmaceutical enterprises come true.

As we all know, medicine is a people's livelihood industry that is directly related to people's health and quality of life. At the same time, the medicine industry is a special industry that has the largest investment in research and development, the longest cycle, relatively more risk factors which is subject to special legal supervision such as drug administration law. Looking over the past 30 years of reform and opening up, it is not difficult to see that the pharmaceutical industry has not been able to truly get rid of the dilemma of simple and low-level duplication and vicious competition in the market. The only choice to get rid of this dilemma is to be at the forefront of world biomedical science. Based on the national conditions and national strength, we believe that while we are trying to achieve the global market sales of products by seizing and copying expired medicines and improving the quality standards of preparations, it will be an important way to achieve this goal to find innovative First-in-class medicines that can be developed simultaneously with foreign countries and participate in international competition.

General Secretary Xi Jinping pointed out: "For many years, there has been a chronic disease in our country that the transformation of scientific and technological achievements into real productive forces is ineffective. Just like the relay race, while the first one has run, there is no one to pick up or know where to run. "

The returnee team headed by Dr. Lu Xianping, with its deep understanding and practice of the current situation of the pharmaceutical industry and its cutting-edge technology in the field of new drug research and development, has stepped out of the road of independent innovation and shortened the distance from the world at the level of First-in-class innovative medicine, which has very positive significance for the innovation of the biomedical enterprises in China. We also hope that the company can sum up and promote their experience, better play a leading role in demonstration in the new era of innovative drug research and pharmaceutical industry development in our country, and make greater contributions in the development process of our country from a large pharmaceutical country to a powerful pharmaceutical country!

Thank you!

Qiu Xuan: Thank Academician Chen for his encouragement and hope for the company. Professor Ma Jun and I exchanged views in the lounge just now, saying that our foreign counterparts are paying close attention to Chidamide and are surprised by the success of the drug market. However, Shenzhen's publicity of Chidamide is too little. Therefore, I think, why is it said that Chidamide is a kind of new drug and an original drug? What special effect does it have in tumor treatment plan? Let's welcome Professor Ma Jun, Director of Harbin Institute of Hematology and Oncology, Director of the Steering Committee of the Chinese Society of Clinical Oncology and Deputy Director of the Asian Society of Clinical Oncology, to tell us now.

Ma Jun: Distinguished leaders, I am a clinical doctor. I was the first batch of overseas students to the United States in 1978 via first Shenzhen and then Hong Kong. It took me an hour to cross the border at Luohu Port, so I was especially impressed by Shenzhen.

As far as lymphoma is concerned, there are about 4 million cases of malignant tumors in China every year, 20 million accumulative cases with malignant tumors in China for a total of five years, about 120,000 patients with lymphoma every year, and a total of 500,000 accumulative patients with lymphoma. Lymphoma in China is usually of a very high degree of malignancy. The age of onset is somewhat old and there is no therapeutic drug. Luo Jing died of lymphoma. Recently, the famous movie star Takakura Ken and Saudi Arabian king also died of lymphoma. Chidamide is a new drug to treat T-cell lymphoma which is not very common in European and American countries, accounting for only 8-10 % of lymphoma. It is a common disease in China, with 1 in 10,000 people suffering from malignant lymphoma. Now that Chidamide is in place, Chinese patients have medicines to use and can survive for a long time. Foreign professors came to China in September this year and were very surprised to see this medicine. The Chidamide developed by China will bring good news to the world.

Chidamide has brought great benefits to patients with lymphoma in China and around the world. Some drug has just been marketed in the United States, but it is intravenous, while Chidamide is oral. We can make patients survive for a long time and even cure them. I am very grateful that Chipscreen Biosciences can push this medicine to China and to the world, so that my patients can be cured if they survive for a long time. We invite questions from reporters and friends. Thank you.

Qiu Xuan: Thank you. The successful development of Chidamide depends on the efforts of clinical experts. Let’s listen to the feelings of clinical experimental experts and welcome Professor Jiang Wenqi, Director of the department of oncology affiliated to Sun Yat-sen University and the vice-chairman of the Oncology Committee of the Chinese Medical Doctor Association, to introduce the relevant information.

Jiang Wenqi: Distinguished leaders, experts and media, I am very glad that I can attend today's press conference. I think today is a very important day in the history of national medicine development. Chidamide is the first medicine to innovate independently.

The development of this drug illustrates two problems. First, the state's support policies and various measures for biomedicine, such as 863 and major projects, have achieved good results. Another important significance is that the returnee team represented by Dr. Lu Xianping returned to Shenzhen, China, where they took root, grew and blossomed, setting a good example for overseas teams to return to China and start their own businesses.

I was once a Shenzhener and the first dean of Shenzhen Medical College here, so I feel very proud. At the recent press conference in Beijing, I mentioned that Shenzhen is a city that focuses on innovation-driven productivity with good policies. If domestic and overseas teams come to Shenzhen to start businesses, they can get good support from policies. Innovation is the characteristic of Shenzhen which can be well supported in Shenzhen. Dr. Lu Xianping's project has won strong support from the state and Shenzhen before it is successful.

Lymphoma is one of the world's top ten tumors, ranked eighth in the domestic male patients with a high incidence. Malignant tumors are threats to human health in the country including Shenzhen. There are about 10,000 cases of malignant tumors in Shenzhen every year, so in Shenzhen, the support of Chipscreen Biosciences is very strong. It's not easy for Dr. Lu Xianping to start a business. It took 12 years to get the drug research and development to market. So I think Shenzhen needs to step up its efforts in promoting innovative biomedical matters in terms of policy. I call for the establishment of a clinical laboratory center, because most of the time the drug is clinically. Clinicians and team of Dr. Lu work together to develop, but the time spent too long. If the clinical Laboratory Center is established in Shenzhen, the progress will be greatly accelerated.

I used to work in the Medical School of Shenzhen University, and now I am concurrently the Deputy Director of Cancer Research Center. With the support of the government in Shenzhen, we have introduced a very good team and the most famous medical and academician in the United States who will bring new drug research and development projects. Therefore, with a good new drug, if all aspects of the system, policy and supporting aspects can be better, I think the innovative medicine, biomedical and innovative technology in Shenzhen will certainly develop better. Thank you.

Qiu Xuan: Thank you. Let’s welcome Dr. Lu Xianping, President and Chief Scientific Officer of Chipscreen Biosciences to publish results. Let's welcome with applause.

Lu Xianping: Distinguished Academician Chen Kaixian, Deputy Director Jiang Yuyang, distinguished guests media friends, hello everyone! First of all, I should on behalf of the Shenzhen Chipscreen Biosciences Co., Ltd. express the heartfelt thanks to the guests attending this conference. Thank you for your support and love for the company for many years.

On December 23, 2014, Chidamide was approved by the State administration of Food and Drug Administration, and the production base of Chipscreen Biosciences has been approved by GMP certification in the middle of this month. Colleagues in the Production Department are working overtime to allow Chidamide to be used in March 2015.

Chidamide is the first subtype selective histone deacetylase oral inhibitor. Its successful development is not only the result of 12 years of exploration and innovation by Chipscreen Biosciences, but also their unremitting efforts to pursue their dreams. It is also the effective guidance of the national, provincial and municipal, drug review and supervision departments, science and technology departments, development and reform departments, and Nanshan Pingshan local government to solve the market allocation problems in economic restructuring and transformation, and also the contribution of our biomedical experts to solve the clinical needs of Chinese patients. Through hard work, Chipscreen Biosciences has been successfully transformed from an early research and development company into a sustainable modern bio-pharmaceutical enterprise that organically integrates research and development, production and sales by taking core technology as innovation and uniting R&D and based on a wide range of original new drug products. Here, I would like to extend my sincerely gratitude to venture capitalists and venture capital organizations that have come along to support our original development.

Medicine is a special commodity, which concerns human life and should be based on science. This concept is the common belief of all workers since the company was founded. The listing of Chidamide also indicates that Chipscreen Biosciences has become a real pharmaceutical enterprise since then, and the legal awareness and responsibility of safe and controllable responsibility to patients will become the highest principle of enterprise management. In the future, we will continue to explore and innovate in the development of the company, develop more original new medicines for unmet clinical needs, and make more efforts to cure diseases and save lives. Thank you again for coming and attending in your busy schedule. Thank you all.

Qiu Xuan: Thank you. The above experts and guests gave a systematic introduction to Chidamide. Now we invite questions from reporters and friends to communicate with leading guests on issues of concern.

Economic daily: Professor Jiang Wenqi, what is the current treatment status of T-cell lymphoma in the world, and what is the treatment effect of the existing drugs?

Jiang Wenqi: Chidamide is very effective in treating T-cell lymphoma. We know that there are many kinds of lymphoma. The diagnosis and treatment of lymphoma are very complicated. It has more than 70 subtypes, and T-cell lymphoma accounts for 23 % of all lymphoma. In terms of treatment, T-cell lymphoma is not as effective as other lymphomas. The general 10-year survival rate of lymphomas can reach 50%-60%, but T-cell lymphoma can only reach 25%-40%, and it has different types, some effects can only reach 20%-25%. There are few new drugs for the treatment of T-cell lymphoma, unlike B-cell lymphoma, which has many molecular targeting drugs. As a lymphoma with Chinese characteristics, T-cell lymphoma has few medicines available. Therefore, this is also the reason why Dr. Lu Xianping has attracted people's attention in the tumor field. He has introduced a new mechanism of action drug, an orally administrable drug. Therefore, this is a great achievement in the field of cancer.

Ma Jun: T-cell lymphoma is relatively rare in Europe and the United States. They are very realistic. They have a lot of B-cell lymphoma, so their research is focused on B-oriented. In China, there are more patients with T-cell lymphoma who are about 23%-35% of lymphoma patients, which is only about a few percent in Europe and the United States. So there is no good treatment in China so far, about 80% T-lymphoma patients die within five years or two or three years. With the Chidamide, we can make Chinese patients have long-term survival opportunities, but we have to do clinical to find whether this medicine can cure T-cell lymphoma, because 12 years of research and development to now is only 1 years of clinical. Why is it called Chidamide? "Chida" is said being the most advanced level in Europe and the United States, "mi" is people-oriented, "de" is said to be safe, but also to live safely. This is my explanation of the Chidamide. Chidamide has a promising future, after the launching on February 6, there will be national experts to combine the program, Dr. Lu Xianping and I will go to San Francisco tomorrow to carry out the relevant introduction. Newspapers such as The New York Times and The Times, and so on, may report that we have developed a drug to treat T-cell lymphoma in China.

The Chinese Voice of CCTV: Dr. Lu Xianping, what is the biggest difference between Chidamide and traditional targeting therapy and chemical therapy? What's the effect of it?

Lu Xianping: There are a lot of drugs for the treatment of tumors, but there are several characteristics of the tumor that cannot be controlled at present, such as tumor recurrence, tumor metastasis, tumor resistance, and tumor escaping from the body's immune surveillance. Epigenetic is the field of scientific frontier that has been emerging over the past decade, and is effective in overcoming drug resistance, metastasis and recurrence of tumors. This is why the potential benefits of the treatment of the tumor in the future can be attributed to the ability of the Chidamide. One of the major differences in the treatment of tumors in the Chidamide is that it selectively activates the anti-tumor immune function of the patient, which is the root cause of the relatively long survival of the patient with the Chidamide.

Ma Jun: By the way, four of my patients have been a later stage, and there is no way to treat the malignant lymphoma with medication. I used this medicine for the patient, now 8 months passed and the effect is very good. There is a 42-year-old woman with tonsil swollen nearly to die. We just used the Chidamide to do clinical experiments to make her take it orally. To now, the basic tumor has been eliminated, and she has survived. The patient's speech is the most authoritative, and the patient's success is the drug's success. The patient benefit is the fundamental.

Guangming Daily: Mr. Lu, creating an original new drug is a process with big investment, high risk, and long cycle. Why has Chipscreen Biosciences persisted so long to achieve ultimate success?

Lu Xianping: In fact, our company was founded 14 years ago as a returnee team with technology and money back. We have successfully completed five rounds of financing in the course of our founding, so I am grateful to venture capitalists and investment agencies, because venture capital is often unwilling to put money in the original field.

First of all, I think we are fortunate to choose a good place, the local innovation atmosphere and market atmosphere are very good. From the second round to the fifth round, shareholders are Shenzhen investors. So Shenzhen is a very open and inclusive city which gives us a good opportunity. We may fluke, because we did not realize these characteristics regarding Shenzhen, but in the past 10 years, we have experienced this. This is an objective factor.

As for subjective factors, I am grateful to such a team. I used to say I was especially lucky to attract a bunch of people who all enjoy the process of research and development. We can do research together, whether it is basic research, or transformation research or clinical research. I am really lucky to have such a team.

As a result of the risk, the money is not enough. We are also very fortunate that Shenzhen Science and Technology Bureau has given us support and help, and then we won the support of the Guangdong Provincial Science and Technology Department, which pushed us to invite bids for major projects. We won one bid in each year of 2002 and 2003, and won the support of Guangdong province, and later, the country 863, 11th and 12th five-year plans continued to support the projects. Without the guidance of national policy, venture capital would not take rounds to invest in it, because investors still need return.

These three factors have brought us to today. The National Drug Administration, provincial Drug Administration and municipal medicine supervisor support us. Our strength lies in research and development, but in the normative production and transformation from an original thing into an industry, we lack experience. The leaders of the provincial bureau and the city bureau gave us care and support to help us carry out risk assessment, so it is entirely from a service point of view to provide us with support. Although we have paid a lot as a company and a team, many of our friends here have given us substantial support. That’s all.

Jiang Wenqi: It's not easy to launch a new drug which needs such good basic scientific research scientists like Dr. Lu, the efforts of pharmacists like Academician Chen, as well as the help of clinicians. Professor Ma Jun and I are clinicians. It also involves the unique vision of venture capital, government support, which are all indispensable. Like a large symphony composed of the various departments, it cannot be combined after being organized together to form a good movement. So this is a very big achievement, Chipscreen Biosciences is a model for entrepreneurship.

Hong Kong Ta Kung Pao: I am a journalist from Hong Kong. I would like to ask if Chidamide is available in Hong Kong. Or is it particularly good for Hong Kongers?

Lu Xianping: This question is particularly good, and I am particularly concerned about it. It is the first drug in the world to develop synchronously in the Chinese original medicine. We will conduct clinical research in the United States, Japan and immediately in the European Union. We also have good cooperation with Taiwan's relevant departments who will approve our first experimental accreditation based on the Chinese population data. Unfortunately, I participated in the Forum organized by relevant organizations in Hong Kong last year to make the data on mainland clinical studies acceptable to Hong Kong health authorities for direct benefit to Hong Kong patients, but Hong Kong is now receiving a British regulatory system, so I also hope that you can appeal to the Hong Kong government for the sake of the patients, let the medicine that really solves the patient's clinical needs get into Hong Kong as soon as possible.

Ma Jun: My classmates in Hong Kong also take this medicine very seriously, although we are one country, two systems. In Hong Kong, the drug can be launched as long as being approved by the United States FDA, and now the first-generation of drugs and second-generation of drugs in the United States will soon be launched in Hong Kong. In the past, we have bought these drugs in HK, but it will be called counterfeit if China does not ratify it. So, I think it would be very nice to have a system so that mainland-launched drugs can be launched simultaneously in Hong Kong. I hope the media can call for the mainland to synchronize with Hong Kong. We are in the same country. Those approved by Chinese Mainland's CFDA should be launched in Hong Kong, just like U.S. FDA. Hong Kong's four famous lymphoma doctors also want the drug to enter Hong Kong. Hong Kong has more than 80 patients with T and N-cell tumors each year, and they should also benefit. I hope you'll go back and call.

Hong Kong Ta Kung Pao: I will make the appeal today. In the past, the mainlanders went to Hong Kong to buy medicine, now I hope that Hong Kongers come to mainland for drug purchase.

Ma Jun: There are doctors in Hong Kong telling me that his patients will come directly to the mainland to buy medicine.

Qiu Xuan: To enhance the value of medicine and expand the impact, all of you here are responsible, and we have to work together.

Due to time, today's conference is at the end. If you want to learn more about the situation of the Chidamide, you can contact with Chipscreen Biosciences directly after the meeting.

I’d like to take this opportunity to wish you all good health and a happy Spring Festival. Thank you.

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