Where is China's stem cell medicine industry development?

Osiris, a company listed on the Nasdaq Stem Cell, whose share price has continued to slump since 2007, has finally seen a wave of upswings. Its stock price has soared by about 80% in the last month. In stark contrast to this, in the context of the rise in the A-share market's medical sector index, the stock price of A-share's sole stem-cell listed company, China Resources and Technology (600645), was in a downtrend channel over the same period.

Behind the ups and downs, it reflects the great expectations of the American capital market after the approved market for Osiris stem cell drugs, and the uncertainties and doubts about the Chinese capital market's approval for the listing of domestic stem cell drugs.

When will China's stem cell drugs be approved for listing? Where does China's stem cell regulation go? This is a big question mark in the minds of many investors in the industry, including those who are interested in stem cells.

The core of the new medical revolution, "regenerative medicine with stem cell therapy as its core, will become another disease treatment approach after drug treatment and surgical treatment, thus becoming the core of the new medical revolution." released by the Ministry of Science and Technology in April 2012. The "12th Five-Year Plan" (publication draft) of the National Major Scientific Research Program for Stem Cell Research made the above assessment of the status of stem cell therapy, which represents the basic understanding of the Chinese government on stem cell therapy.

Stem cell research has thus been elevated to a strategic level, and the country has great expectations for stem cell clinical medicine, an industry authority said.

Yu Yang, the first entrepreneurial pharmaceutical industry analyst, told the Securities Times: “In the biological industry of one of the country’s seven strategic emerging industries, stem cell clinical research ranks first in the support of the biomedical sector. Currently, 863/973 and the National Nature Fund All have a stem cell research fund and clearly support the clinical application of stem cells."

In the United States, in March 2009, soon after the US President Barack Obama took office, the government sponsored the ban on embryonic stem cell research. However, in August 2010, a US state court suspended this, but then the US District of Columbia Circuit Court of Appeals ruled on September 28, 2010, allowing the government to continue supporting embryonic stem cell research. While the United States was still arguing about the ethical issues of stem cells in the United States in 2009, the US Food and Drug Administration (FDA) quickly approved the listing of various stem cell therapies.

In the eyes of Yang, this seemingly contradictory measure reflects the US government’s high priority for stem cells.

Since then, relevant regulatory authorities in Canada approved the launch of the stem cell drug Prochymal developed by Osiris in the United States in late May 2012. New Zealand then granted the company's stem cell drug marketing license on June 15. Osiris, which has had a long-term downturn in its stock price, has also surged by 80% in the past month.

According to the Securities Times reporter, even though the drug is currently not officially approved for listing in the United States, the drug was actually included in strategic supplies by the U.S. military four years ago. In Korea, the clinical application of stem cells has developed rapidly in recent years, and relevant authorities believe that three stem cell drugs may be approved in the near future.

However, in terms of specific clinical treatments, China has repeatedly been criticized by foreign counterparts in recent years. The world-famous "Nature" magazine has twice criticized China's illegal stem cell therapy in recent years.

For this kind of stem cell treatment chaos, the Ministry of Health and the State Food and Drug Administration jointly issued the "Notice on Conducting Stem Cell Clinical Research and Application of Self-examination and Self-correction Work" in early January 2012, and decided to jointly carry out a one-year stem cell clinical study. Research and apply the specification rectification work.

It is explicitly proposed to stop the activities of stem cell clinical research and application that have not been approved by the Ministry of Health and the State Food and Drug Administration; and stop all new project declarations before July 1, 2012. It is reported that the Ministry of Health has set up a leading group for stem cell reorganization and a rectification work office. The minister and deputy minister of the Ministry of Health will serve as the leader and deputy leader of the leading group.

The Securities Times reporter learned from relevant authorities in the industry that the results of investigations conducted by the Stem Cell Reorganization Office after investigation revealed that stem cell therapy has become a new treatment option for major diseases such as cardiovascular diseases, blood system diseases, and nervous system diseases; According to surveys, adult stem cell therapy has been carried out in about 300 hospitals and institutions in China, covering more than 100 types such as hematological diseases, lymphoma, myocardial infarction, liver cirrhosis, diabetes, and anti-aging beauty. However, the source of stem cells used is endless. In the same way, the safety of the clinical use of these different sources of stem cells is also lack of systematic evaluation.

In the recent “2012 Cell Therapy Technology Symposium” that has not been accepted for approval of stem cell projects in the past seven years, Wu Zuze, an academician of the Chinese Academy of Sciences, believes there are three main differences between China and the United States and South Korea in stem cell therapy: First, China has not yet established a unified quality. Inspection standards and quality inspection acceptance units cannot be used on a large scale; secondly, the approval procedures and regulatory rules for the clinical research and application of stem cells have not been formed yet, and they need to be streamlined; third, some units have made excessive and unscientific business. Hype, causing negative effects.

It is the third point that has led to sharp criticisms of China by foreign counterparts. The root cause lies in the second point, that is, China has not yet implemented the clear responsibility for the supervision and management of stem cells, nor has it established approval procedures for clinical research and application of stem cells. And monitoring rules.

Many authorities in the industry believe that who will supervise the research and clinical application of stem cells is a core issue that is related to the progress and prospects of the development of China's stem cell industry. But precisely on this key issue, people in the industry generally believe that they do not understand, and do not know whether the Ministry of Health or the Food and Drug Administration is responsible for the relevant supervision.

"At present, stem cell therapy has no rules to follow, and it is impossible to rely on it. The most fundamental cause of this chaos is the imperfect and lagging state regulations governing the approval and application of stem cell products." Professor Han Zhongchao, director of the National Stem Cell Engineering Technology Research Center, accepts the Securities Times. An interview with reporters said.

According to the introduction of Han Zhongchao, in May 2009, the relevant authorities issued a document stating that stem cells should be set as the standard for the third category of medical technology. “The relevant standards have been basically established, but they are not implemented at the end, and they do not know what the reason is. , has been delayed until now has not been implemented."

The Securities Times reporter learned that, probably in 1999, the State Food and Drug Administration was responsible for supervising stem cells. At that time, the Ministry of Health and the Food and Drug Administration had just separated, but after a few years, the Food and Drug Administration slowly took no notice. In 2005, the General Office of the Ministry of Health issued a notice to the Department of Health of Heilongjiang Province on the identification of cancer immunosuppressive therapy. It was stated that the in vitro cell culture of tumor immune resuscitation therapy is a clinical technique. This means that the stem cells that were originally regulated as drugs have been defined as medical technology and the Ministry of Health has exercised supervision and management rights.

Afterwards, the State Food and Drug Administration's Registration Department stated in a documentary letter of the Shanghai Food and Drug Administration in 2007 that in 2006, the State Legal Affairs Office convened a national preparation committee, the Ministry of Health, and the Food and Drug Administration to jointly discuss the decision to apply somatic cell therapy to individuals. The inability to manage in large scale according to the medical treatment of medical institutions does not fall within the scope of management of the Food and Drug Administration. This formally shows that the Food and Drug Administration has withdrawn from the supervision of stem cells.

In 2009, the Ministry of Health issued the No. 18 document of Wei-Mei-Gong-Fa [2009], which is the "Measures for the Management of Clinical Application of Medical Technology." It shows that the Department of Medical Affairs of the Ministry of Health officially takes over the supervision and management of stem cells.

However, relevant industry sources stated that despite the many reported stem cell projects, the Department of Medical Affairs of the Ministry of Health has so far not approved which institution and has not organized relevant assessments. That is to say, from the Ministry of Health General Office of the Ministry of Health in 2005 to the Department of Health of Heilongjiang Province issued a notice regarding the identification of tumor immunological resuscitation therapy for seven years, and since March 2009, the "Management of Clinical Application of Medical Technology" has been issued. For more than three years, the Ministry of Health did not approve or organize any review of any related stem cell projects.

With little coordination, the Ministry of Health has not yet accepted and approved clinical treatment of stem cells other than any hematopoietic stem cell technology. At present, all types of stem cell therapy in society are popular and even led to the "stem cell tourism," that is, foreign patients. Traveling to China to receive unapproved stem cell therapies has triggered an international well-known scientific journal Nature to issue a double-questioning question about China's out-of-control of stem cell management.

Overseas counterparts look to the Chinese market For the success of the United States and South Korean counterparts in stem cell drug market approval, China's stem cell companies are rather helpless.

"So far, the State Food and Drug Administration has only accepted five applications for clinical trials of new stem cell drugs, of which only two have been approved for clinical trials, but clinical trials have been suspended since the end of the second phase; we are the third clinical report in 2006. The trial was accepted by the State Food and Drug Administration in February 2007 but has not yet been approved for clinical trials and is pending.” Han Zhongchao told the Securities Times reporter: “We all say that research and development of stem cell regenerative medicine products represent a new direction, but Currently, only the stem cell bank technical service has produced economic benefits, and other stem cell products have not made any money because they cannot enter the market, and if they have made money, they are also fighting the sidelines. The rules have not been set, and the products are not available on the market. VC/ PE (risk investment / private equity investment) did not dare to come in."

It is reported that at present, the development of a stem cell drug in the United States will require about 500 million U.S. dollars, and in China it will probably need 50 million to 100 million U.S. dollars. In Han Zhongchao's view, the investment community is still mainly worried about policy risks. This has become one of the main factors that hinder the development of the industry. Since last year, there have been several international stem cell products approved as drugs that can be listed on the market. This gives stem cell experts and Investors gave a shot of strength and hope that these progresses will give the government regulators a certain amount of assurance.

"We currently have 7 to 8 drugs, and if the market share for the batches will be several billion yuan, it may be wider than the current application of antibody drugs that are sought after by the market. But at present, none of them has been approved, and all are waiting to see it. Taking up a lot of money and riding a tiger is difficult. If you don't develop your skills before you develop, then you don't know when you can break through this current policy dilemma," said Han Zhongchao.

Han Zhongchao believes that the state must first have a plan for the stem cell industry. Whether stem cells can become an industry depends on whether it has practicality and whether it can go to the market. To achieve this goal, we must formulate relevant laws and standards, and only then can companies know where to go? What efforts should be made to develop in accordance with what laws and standards should be followed, and at the same time, the government must establish a fair and competitive industrial environment through laws and regulations. Only in this way can we really promote the development of strategic emerging industries.

More importantly, according to industry sources, cell therapy abroad is currently trying to enter the Chinese market. Last year, relevant US commercial organizations required China to remove the development and application of human stem cells and gene diagnostics from past prohibition projects, allowing them to Enter China's stem cell therapy market; and in the current context that stem cells and drugs have already been approved for listing in some countries, such calls will become even more intense. If China is not prepared, it will be in a more passive state.

At present, there are more than 20 related stem cell listed companies in the United States, which are listed on different exchanges. Among foreign stem cell companies, there are separate professional stem cell companies, and some are subsidiaries of multinational pharmaceutical giants. Many of the world’s pharmaceutical giants either enter the stem cell area through mergers and acquisitions or have cell therapy departments or R&D centers within the company.

It is worth noting that in the first half of the self-examination and self-determination phase, the Stem Cell Reorganization Office of the Ministry of Health is working out the Guidelines for Stem Cell Clinical Research (Interim) and Stem Cell Clinical Research Base Management (Preliminary Draft). On April 17, the Ministry of Health set up an expert committee on stem cell reorganization. The following two documents will be discussed the next day. It is understood that these two documents are still in discussion papers, there are no final drafts, and there are still many issues that need clarification and further discussion. The second special discussion may be held before the end of June, and some unanswered questions may be answered positively by then.

It was also learned that after the preparatory meeting was opened in March, the Chinese Medical Doctor Association officially approved the establishment of the Clinical Application Committee for Regenerative Medicine and Cell Therapy of the Chinese Medical Doctor Association in May. It has now begun operations. Yang Jing, executive deputy chairman and secretary general of the Chinese Medical Doctor Association, is the chairman of the committee, and Cai Zhongjun, deputy chairman of the Chinese Medical Doctor Association, is the deputy chairman. The situation in which the two vice-chairmen chaired the same secondary institution or committee affiliated to the association at the same time is quite rare in the Chinese Medical Doctor Association, which shows that the institute pays full attention to the application of regenerative medicine and cell clinical application.

In addition, relevant experts of the Chinese Medical Doctor Association stated that the definition of the third medical technology has been changed in the "Medical Technology Clinical Management Regulations (Revised Opinions)" of the Ministry of Health in 2012, and the "safety and effectiveness" of the 2009 edition It is still necessary to further verify through standardized clinical experimental research that “it has been changed to “exact and effective”. This shows that the country is trying to put forward higher requirements for the safety and effectiveness of stem cell therapy.

The real decisive moment will be after July 1. According to the Ministry of Health’s previous schedule, the application for the stem cell clinical research project will be re-submitted on July 1.

“The road is tortuous and the future is bright. As for how to walk, it takes a little patience. Although stem cells do not make money now, once the policy is passed, the industry will move toward a fast-paced path because only useful things will be There is a market," said Han Zhongchao.

Food & Feed additive

Food & Feed additive,High Quality Food & Feed additive,Food & Feed additive Details, CN

Xi'an JCF Herb Technology Development Co., Ltd , https://www.jcfherb.com