Half-Hour Economy Pays Attention to Major Innovation of Scientific and Technological Achievements: New Domestic Anti-Cancer Drugs Covered in Medical Insurance

August 31,2017

Source: CCTV.com

Currently, cancer has become one of the major diseases that harm people's health. People feel jittery at the mention of cancer which is often cureless, especially in the advanced stage. Even if it is curable, it costs a lot of money. However, the situation is changing.

[Death might come at any moment due to suffering from cancer, and her life was saved thanks to the new anti-cancer drug chidamide]

At 9 am, Xing Wenyan came to Beijing Luhe Hospital, Capital Medical University for reexamination with her mother. Every other month, Xing Wenyan will come to the hospital with her mother Zhang Zonghua to find the attending doctor Zhou Hebing of Hematology Department for health examination.

Director of Hematology Department of Beijing Luhe Hospital, Capital Medical University Zhou Hebing: The patient is in good condition, so is her mental state. She has put on weight of more than10 kilograms, and I didn’t find any lymph nodes.

Zhang Zonghua has kept reexamination and return visit like this in the past two years. 2017 is the third year since Zhang Zonghua was diagnosed T-cell lymphoma. In Apr. 2015, Zhang Zonghua suddenly suffered a high fever which lasted after receiving various treatments. Later, she got a shocking result from the Hematology Department of Luhe Hospital that she had been infected with advanced vascular immunoblastic lymphoma, a type of peripheral T-cell lymphoma that is extremely fatal.

Zhou Hebing: Chances of 5-year survival period is generally about 30%. This patient is relatively late in stage, so her life cycle is relatively short in the case of normal chemotherapy, about one year.

Chairman and Professor of Union for China Lymphoma Investigators Ma Jun: Lymphoma in China used to have a low incidence rate, but rises rapidly in recent years. Now it has exceeded leukemia with a percentage of 7.8 per 100,000, i.e., there is one case of lymphoma in every 10,000 people. In the past, immunochemotherapy did gain much progress. However, there were no drugs available for T lymphoma, such a common disease in China.

After receiving the examination result, the whole family were so sad. Zhang Zonghua must receive treatment immediately. The traditional method of treating lymphoma counts on chemotherapy. However, the violent reaction after chemotherapy made Zhang Zonghua suffer a lot. And the chemotherapy has little effect. Zhang Zonghua was still caught in fever, cough, swollen lymph nodes, and edema all over. At the age of 67, it’s difficult for her to bear the harm caused by chemotherapy.

Just as the whole family was at the end of their resources, in Mar. 2015, a new drug named chidamide was launched. This is an oral drug. After performing twice chemotherapy, the attending doctor Zhou Hebing decided to treat Zhang Zonghua with combined therapy of chidamide and chemotherapy, hoping to raise the remission rate from 58% to 80%.

However, what surprised Zhou Hebing was that the therapy brought an instant effect after Zhang Zonghua taking chidamide, basically stabilized after the fourth course of treatment until the chemotherapy was ended in December.


Zhou Hebing told us that for internationally recognized refractory T-cell lymphoma, there’s high recurrence rate with the use of chemotherapy alone, and patient's survival time is generally about one year. However, after adopting a targeted new drug of chidamide, the patient quickly recovered with no recurrence.

Xing Wenyan: She used to count on others to feed her. Now she can do it by herself, even cook by herself. She’s much energetic now, usually going for a stroll. I really think that she’s much better.


Like Zhang Zongying, Wu Min from Shenzhen City was also a patient who was rescued from the death line. In 2013, Wu Min was diagnosed as advanced T-cell lymphoma. At that time, there was no molecular targeted drug in China, and she could only be treated using conventional chemotherapy. Wu Min was poorly tolerant to long-term chemotherapy. In 2014, she even suffered deep coma for two months.


The torture of cancer and adverse effects incurred by chemotherapy was insufferable for Wu Min. Her life was hung by a thread, and series of notices of critical condition were released to her family from Peking University Shenzhen Hospital.


Wu Min’s husband Wang Cheng: I was crashed inside. How can I retain a peace of mind to think that my better half who has accompanied me for decades will leave like this? And my child just couldn’t stop crying.


Rescued by the doctor, Wu Min escaped from death over and over again. But after each wake up, she was faced with forthcoming coma. In 2015, after two years of torture, an innovative anti-cancer drug, chidamide, came out. Wu Min and his family decided to give a shot at this new drug. Surprisingly, the condition was under control. Now Wu Min has been taking the medicine uninterruptedly, which helps her stabilize the condition and maintain a life of quality.


Wu Min: I feel much better now, and there is no recurrence of edema, fever, or erythema.

[Domestic drugs caused a sensation. For the first time, foreign pharmaceutical companies introduced patents from China for development]


T-cell lymphoma is a type of tumor with a high degree of malignancy. The incidence of this disease in China is about 50,000 per year, with a five-year survival rate arriving only at 25%. The two patients we have just mentioned found effective control of the disease after taking chidamide. So what kind of anti-cancer drug is this chidamide?


Chidamide is a new anti-cancer drug independently researched and developed by China, specifically, by a company named Chipscreen Biosciences in Shenzhen. After conducting hundreds of thousands of experiments, this innovative R&D team discovered a type of enzymes with high-molecular weight. These enzymes are almost involved in all cellular activities. Chidamide controls tumor recurrence and metastasis by precisely controlling the four enzymes closely related to tumor cell activity and activating the immune function of anti-tumor cells in humans.


President and Chief Science Officer of Shenzhen Chipscreen Biosciences Co., Ltd. Lu Xianping: Chidamide is a histone deacetylase inhibitor, which plays a key role in regulating gene expression, i.e., it turns off good genes, and turns on bad genes. Therefore, by drawing on this inhibitor, we reversed the process to reopen the good genes, and turn off bad genes. We re-programmed the uncontrolled cells and returned them to a controllable state. Through such a mechanism of action, it is possible to stop the growth of tumor and take tumor under effective control.


Lu Xianping, President of Shenzhen Chipscreen Biosciences Co. Ltd., is the foregoer of this R&D team consisting of returnees. On May 22, 2015, a piece of news evoked social concerns. Chidamide, an original anti-cancer drug with independent intellectual property rights in China, was approved to be launched in China, and became the first original innovative chemical drug granted clinical research in developed countries such as the United States. The indications of the first batch were recurrent or refractory peripheral T-cell lymphoma. The news of China's successful and independent development of anti-cancer drugs caught the eyes of the whole world since its release. Time, Forbes and other magazines went to great length to report the news, causing a sensation, for it signified that China finally developed its own original anti-cancer drug. And at the same time that Shenzhen Chipscreen Biosciences Co., Ltd. has authorized the overseas patent development right of chidamide to a US company, which features the first overseas patent licensing of China's original innovative drug.


Lu Xianping: T lymphoma is incurable in China, with high degree of malignancy and fast progression. Chidamide produced the best benefits and safety in this field, so we made it happen.


Ma Jun, chairman of Union for China Lymphoma Investigators, told reporters that since clinical research in 2014, more than 1,700 people in China have used chidamide. More than 300 patients with lymphoma he treated have achieved satisfied outcomes after taking this domestically produced innovative drug.


Ma Jun, Chairman of Union for China Lymphoma Investigators said that among 768 patients, the complete remission rate is about 32%. If we count into what we referred to as partial remission, it may reach between 58% and 62%. It is a rare case that a single medicine can achieve such desirable curative effect.


In the 1990s, after finishing Ph.D. study in molecular biology and oncobiology at Peking Union Medical College, Lu Xianping went to the United States and studied his postdoctoral research in the Department of Pharmacology at the University of California. In 1998, Lu Xianping, only 36 years old, became the R&D director of Galderma North American Center, a large-scale multinational biopharmaceutical company. Although he has already sat on a senior executive of a US company, Lu Xianping has always been concerned about the development of pharmaceutical industry in his motherland.


Lu Xianping: When I came back to China to start business, virtually around 98% of China's pharmaceutical market is dominated by generic drugs, with innovative anti-cancer drugs in extreme scarcity.


It has always been a primary concern for Lu Xianping to develop innovative drugs affordable to the general public. In 2000, Lu Xianping gave up his high-paying job and superior life in the United States, left his wife and two young children there, back to China alone, and joined five senior executives, US returnees, of multinational pharmaceutical enterprises such as Ning Zhiqiang and Cheng Jing and university professors to establish Shenzhen Chipscreen Biosciences Co., Ltd., on a mission to make veritable original innovative drugs in China.


The development of original innovative drugs is definitely not an easy task. It is commonly accepted in international pharmaceutical industry that: it is hard to escape from the "double ten" spell to develop an innovative drug. It takes 10 years and an investment of 1 billion dollars to pay off. The process is extremely difficult. High risk, high investment, and long investment period discouraged most pharmaceutical companies.


When it’s established in 2001, Chipscreen Biosciences received a venture capital investment of 50 million yuan and their research began. But soon the R&D team realized that the fund was just a drop in the bucket for the huge R&D costs that needs constant investment. The R&D investment of innovative drugs is growing like a “bottomless black hole”, bigger and bigger. Confronted with market and policy pressures, the company was cornered in a dilemma in 2005. On the one hand, there’s no way for financing, and on the other hand, the old shareholders stopped investing more. The R&D team consisting of more than 20 returnees almost faced an impasse.


To save expenses on research and development, Lu Xianping, the leader of this returnee team, immediately made a bold decision: 60% of the salary of the returnee team was cut, which reduced a lot R&D costs of the company, but it also made it difficult for many scientists in the team to support their families overseas with such wage levels. Several returnee founders had to choose leaving the entrepreneurial team regrettably. From 2004 to 2006, due to shortage of funds, Chipscreen Biosciences had a difficult time in operation, but meanwhile, the team succeeded in the promotion of innovation and research. For the first time in China, two original innovative drugs were approved in applying for human experimentation.


To get out of the dilemma as soon as possible, Lu Xianping licensed the patent development rights of “chidamide”(except in China), which was just completed preclinical evaluation, to a US company for joint development, and this was unprecedented in the history of Chinese medicine. Moreover, the chemical genome screening platform independently built by Chipscreen Biosciences was open to multinational pharmaceutical companies and research institutes, thus obtaining urgent needed R&D funds.


All the time, China's pharmaceutical industry was dependent on introduction of advanced patent technology from overseas, but Chipscreen licensed patent technology to an overseas company and achieved gratifying results. This move immediately let domestic investors see the value of China's original innovative drugs, rushing to negotiate with Chipscreen for investment opportunities. The second round of financing of Lu Xianping's returnee team was finally completed in 2007.


After eight years of phase III clinical trials, going through arduous and tortuous, in Dec. 2014, the original anti-tumor drug chidamide was finally approved by China Food and Drug Administration for sale and became the first medicine licensed for sale after phase II clinical trial in China. Chidamide was the first that realized absolute Chinese original in the field of chemical medicine from structural discovery to industrialization. Zhang Zonghua and Wu Min were among the first batch of patients who have benefited from the innovative drugs.


Wang Cheng: We bought chidamide once it came out on market, not matter how expensive it was. I bought this medicine at my own expense at first, totaling 160,000 yuan, plus the money spent on treatment in the early period, I approximately spent total 800,000 yuan.


In the interview, the reporter learned that, there were only four innovative drugs targeting for the treatment of T-cell lymphoma in the world, including chidamide. Two of them have been launched for sale in the US, and the monthly treatment cost is as high as 280,000 yuan and 140,000 yuan. Wang Cheng told the reporter that one packet of chidamide costs 13,280 yuan, and patients normally take two packets a month. In contrast, the efficacy and safety of chidamide is the best, and the monthly cost is only more than 20,000 yuan, far lower than similar drugs introduced from abroad. But even so, for many lymphoma patients, it is still a heavy financial burden. After chidamide was launched on market, Chipscreen Biosciences immediately launched charitable donation program. The value of donated drugs has exceeded 80 million yuan, and so far around 7-8 hundred people have been benefited. Although investors strongly against it, Lu Xianping persisted in doing the things he thinks right.


Lu Xianping: President Xi once said that we should develop innovative and original medicine affordable to the general public in China. That’s what we have envisioned when we created Chipscreen Biosciences more than ten years ago.


On Jul. 13, 2017, China's self-developed anti-tumor drug chidamide was successfully included into the new National Reimbursement Drug List, which means that patients can get access to this innovative drug by spending roughly only a thousand yuan a month. Lu Xianping told us that after chidamide launch on market, the R&D team was expediting their study on chidamide combined with other endocrine anticancer drugs in treating advanced breast cancer.


At present, the randomized and double-blind phase III study of chidamide combining with other anti-tumor drugs for the treatment of advanced breast cancer has been carried out in more than 20 hospitals across the country. The epigenetic regulation mechanism of chidamide will likely reverse the resistance, metastasis or recurrence caused by endocrine therapy, bringing real benefits to breast cancer patients.


In the meantime, chidamide is expanding its research on indications. According to experts, chidamide has good curative effects in treating some cases of lung cancer and leukemia, including clinical studies of various diseases such as hematologic neoplasms, solid tumors and AIDS currently underway.


Chairman of Union for China Lymphoma Investigators Ma Jun: This drug has amazing effect and we are now expanding our research with 24 clinical studies in the pipeline, joined by countries like Japan and the United States. It can be very effective against other types of tumors, and now we are broadening our study on indications. Once we find in the next two years that it works against diseases such as acute myelogenous leukemia, GVHD after hematopoietic stem cell transplantation, lung cancer or breast cancer, even other tumors, which are highly prevalent in China, it will be something anticancer and broad-spectrum, like our broad-spectrum antibiotics, holding great prospect.


For all those years, the anti-tumor drugs used by our Chinese people were imported from foreign countries at premium price. And now chidamide is going global and is being recognized and accepted by developed countries in Europe and America. It is expected to become the first Chinese original innovative drug launched in countries with regulated market.


Half-Hour Observation: Develop life-saving drugs that people can afford


Just a few years ago, there were few quality original innovative drugs, but today, we have achieved tremendous development for that. Such change benefited from the hard work of the great majority of scientific and technical personnel as well as policy support. In recent years, our country has been strengthening support for the research and development of innovative drugs.


About 13 billion yuan was invested in the national science and technology major project of “major new medicine development” during the period of “the 11th Five-Year Plan” and “the 12th Five-Year Plan”, which mobilized investment from social sectors, local government and enterprises. At the same time, the state has introduced varied new strategies in multiple aspects such as new drugs approval and medical insurance coverage. These strategies are becoming a powerful driving force for new drugs research and development. We believe that in the future, more and more domestically produced and affordable innovative drugs will be available and bring real benefit to the public.

Video link:http://tv.cctv.com/2017/08/31/VIDEj6kWds47NmTTC7AXawHZ170831.html

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