As soon as the end of this month, the revised “Listing Rules” of the HKEx will be officially launched, opening an IPO window for unprofitable biotech companies. From the moment the consultation document was published, the eyes of the capital market focused on the biomedical “unicorn” representing China’s innovative power.

"The reform of the HKEx is a great encouragement for innovative R&D companies. We are also studying and studying. There is still no decision on the listing." Dr. Wang Changjin, President of Nanjing Frontier Biology, said in an interview with Time Weekly.

It is reported that after 15 years of hard research and development, the first anti-AIDS drug “Aiboweitai” of Frontier Biology has submitted a listing permit to the State Food and Drug Administration and entered the priority review channel, which is only one step away from the listing. If approved successfully, this will be China's first anti-Ai Xin drug, the world's second long-acting anti-Ai Xin drug.

Capital road

The frontier organism was first founded in 2002 by a team of returnees scientists. At this stage, the focus is on the development and promotion of innovative drugs in the field of AIDS antiviral therapy and pain.

According to the data, the company's largest shareholder is Hong Kong Jianmu Pharmaceutical, and the actual controller is Dr. Xie Dong, a returnee scientist. Among the core members of the team, Chairman and Chief Scientist Xie Dong, President Wang Changjin and Vice President Lu Rongjian are all special experts of the National “Thousand Talents Program”.

As an entrepreneurial company, cutting-edge organisms have been investing in new drug research and development for 16 years. Since all products are still in the stage of new drug review or clinical trial, and no products are on the market, the frontier organisms have not yet been profitable.

In fact, in view of the funding needs for continuous R&D investment, cutting-edge organisms have long had plans to land in the capital market. Time Weekly reporter noted that in September 2016, Frontier Biology submitted the listing application materials to the National Small and Medium Enterprise Share Transfer System Company (referred to as the “share transfer system”), and the sponsor broker was Industrial Securities.

The public information on the listing review of the stock transfer system showed that the application for listing of leading-edge creatures had its first feedback at the end of November 2016, but no further progress has been made since then.

"There was indeed a plan for the new three board. Later, I listened to the opinions of shareholders and other parties, and also considered the liquidity of the New Third Board and finally gave up the listing." Wang Changjin told the Times Weekly reporter.

However, in 2016, cutting-edge creatures successfully completed two rounds of financing. According to the disclosure of the publicly disclosed manual, in April 2016, the frontier creatures received investment from Nanjing Qigong, Yifeng Taihe and Yuhang Chunhua, with a total investment of 48.4 million yuan.

At the end of December 2016, Frontier Biology announced that it has completed the C-round financing of 300 million yuan. The financing was led by Huaxin Century, and it was invested by institutions such as Shenzhen Venture Capital and Yifeng Venture Capital. The company said that the funds raised are mainly used for the industrialization, market development, new product development and company operations of Aiboweitai.

At the beginning of this year, the Hong Kong Stock Exchange launched the reform of the listing system, opening up an IPO channel for innovative biotech companies that have not yet made profits, and inspiring the entire biomedical industry. As an unexplored new drug research and development company, cutting-edge creatures also ushered in the window of IPO. Wang Changjin told the Times Weekly reporter: "At present, the company is still studying relevant policies in various capital markets, and Hong Kong is the focus of consideration."

Betting AIDS treatment

Anti-AIDS drugs have been a hot research topic in the global medical field due to the huge unmet clinical needs. In recent years, through antiviral treatment, AIDS has shifted from a fatal disease to a chronic disease that requires lifelong medication.

According to data from the China Center for Disease Control and Prevention, from January to September 2017, 105,000 new cases of AIDS were reported in China. As of the end of September 2017, China reported 747,000 cases of HIV-infected and AIDS-infected people.

According to the UNAIDS report on ending AIDS in 2017, about 36.7 million people worldwide are infected with HIV, and 19.5 million of them have received antiretroviral drugs.

In 2002, when several scientists, such as Xie Dong, returned to China to start a business, they targeted this promising field. After more than ten years of technology accumulation, cutting-edge organisms have established a long-acting peptide drug research and development platform with global intellectual property rights. Aiboweitai is the first innovative drug on this platform.

According to the data, Aiboweitai is a long-acting HIV fusion inhibitor. It is China's first independent innovation, global anti-AIDS drug, and the most popular long-acting anti-AIDS drug in the world.

“This is a national 1.1 new drug that we independently researched and developed for 15 years.” Wang Changjin told Time Weekly that the interim results of Phase III clinical trials of Aiboweitai in 2016 reached all the preset clinical endpoints. In July of that year, Abbott's listing application was accepted by CFDA and entered the priority review. “Although the time for approval is still uncertain, it should be faster.”

Currently, AIDS treatments on the market are oral dosage forms and need to be taken 1-2 times a day. As a long-acting drug, Abbottai only needs one injection a week.

Frontier organisms also have a layout in the combination of drugs. In July 2017, Frontier Bio and the Rockefeller University of the United States completed a licensing transaction and obtained a global patent license for a broad-spectrum neutralizing HIV antibody 3BNC117.

"AIDS treatment must be 'cocktail' therapy, that is, combination therapy. The broad-spectrum neutralizing antibody 3BNC117 is the fastest progress in the world, the curative effect is accurate and shows the effect of immunotherapy. The introduction of antibody 3BNC117 is in order to cooperate with Aiboweitai. Compose our own full-injection long-acting new drug 'cocktail' formula. This long-acting new drug combination is expected to replace oral drugs and conduct clinical research on the functional cure of AIDS, which is currently a promising functional cure combination worldwide." Wang Changjin Said.

In addition, there is another innovative drug, AB001, on the R&D pipeline of cutting-edge organisms. According to the data, AB001 is a new type of transdermal patch analgesic introduced from ABSize Japan for the treatment of acute and chronic muscle and joint pain. A phase II clinical trial in the United States has been completed to treat patients with chronic low back pain and achieve a statistically significant endpoint. In the next step, clinical trials will also be conducted in China.

Global layout

The data shows that the global AIDS drug market has reached US$25.3 billion in 2017, with an average annual compound growth rate of over 8%. In China, AIDS drugs are mainly procured by the government and distributed free of charge. There is a huge gap between the market scale and the developed countries.

Leading-edge organisms position themselves as innovative biopharmaceutical companies based in China and facing the global market. As Aiboweitai's domestic approval is approaching, leading-edge creatures are accelerating their registration in the international market.

"At present, we are actively communicating with relevant departments of several 'Belt and Road' countries. We hope that after the listing of Aiboweitai in China, we can start registration and approval in these countries as soon as possible, and accelerate the listing and sales in developing countries. Wang Changjin said to the reporter of Time Weekly.

At the same time, Aboweitai and the antibody 3BNC117 combined with a full-injection long-acting new drug combination, will also carry out clinical trials in both China and the United States, double-double.

"This work is in the midst of preparations. We have already passed the FDA and will be able to conduct clinical trials in the United States in the second half of this year. China is also communicating with CFDA, and it is expected that clinical trials will be reported this year." Wang Changjin said .

From the company's recent personnel arrangements, you can also get a glimpse of one or two. Recently, Frontier Biotech announced the appointment of Dr. Zhang Huyi and Dr. Bao Jing as the company's deputy general managers, responsible for global registration and global clinical development.

According to public information, Zhang Huyi was responsible for the international registration of Xiansheng Pharmaceutical before joining the frontier organisms. He was a FDA reviewer. Bao Jing has served as a project officer and medical officer at the National Institutes of Health (NIH) AIDS Division for 16 years, managing and directing international multi-center clinical development in Africa, Asia Pacific, Europe and the United States. (Time Weekly)

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