Crown bio-investment bet phenenimod listed to open a new space for psoriasis medication

Securities Times reporter Li Yingquan Zhang Yang

On August 11, Guanhao Biological announced that it intends to acquire 53.35% of Beijing Wenfeng and 53.35% of Zhonghao Pharmaceutical from the controlling shareholder Guangdong Zhiguang for 266 million yuan. Since the acquisition of 5% of Beijing Wenfeng's equity in Guangdong Zhiguang in 2016 and the same proportion of investment in Zhonghao Pharmaceutical, after the completion of this transaction, Guanxiong's holdings of Beijing Wenfeng and Zhonghao Pharmaceuticals The proportion of shares will reach 58.20%, and Guangdong Zhiguang will no longer hold the shares of the two companies.

The acquisition of Guanxi Biological is aimed at the new drug phenene mound developed by Beijing Wenfeng. At present, the drug has submitted a new drug application to the State Food and Drug Administration (CFDA), which has been included in the priority review category after review and demonstration by CFDA experts. This medicine can provide a good therapeutic effect on psoriasis (commonly known as psoriasis) and eczema, which are currently difficult to cure in dermatology.

Zhang Jianzhong, an authoritative expert in the field of dermatology in China and director of the dermatology department of Peking University People's Hospital, praised phenenimod as a "revolutionary drug" in an interview with the Securities Times reporter e. The crown biota also said that the listing of phenenimod is expected to change the Chinese doctor's awareness of psoriasis.

Bet Benzene Mold was approved for listing

According to the announcement, Beijing Wenfeng is a pharmaceutical R&D enterprise. The core research and development product is the national 1.1 new drug phenene mound. It is a small molecule chemical for the treatment of inflammatory and autoimmune diseases. It is mainly used to treat silver scurf and eczema. Such diseases have been listed as major scientific and technological projects of the Ministry of Science and Technology's "12th Five-Year National Major New Drug Creation".

Zhonghao Pharmaceutical, which was acquired together with Beijing Wenfeng, is a pharmaceutical production, processing and sales company, which is mainly responsible for the production and sales of benzomethod. According to financial data, Beijing Wenfeng and Zhonghao Pharmaceutical did not realize operating income from January to June this year, and the net profit was -605.89 million yuan and -416.21 million yuan respectively. In other words, the earnings prospects of both companies are almost bet on the approval of Benzene Mold.

Guan Yusheng also admitted that the biggest risk of this acquisition is the uncertainty of phenenimod obtaining a drug registration certificate. In addition, as a new drug, phenenimod may have a lower sales volume and sales amount in the short term, and the gross profit margin is lower or even negative. The company will continue to expand the market awareness of new products through academic promotion and promote products. Sales, so there may be a long promotion period, high marketing costs and so on.

In response to the above risks, Guanxi Biological and Guangdong Zhiguang agreed on the subject share repurchase. If before Beijing, December 31, 2017, Beijing Wenfeng did not obtain the new drug certificate for phenenable cream, and the company has not obtained the GMP certificate related to the production of phenenimod cream, the company has the right to request Guangdong. Zhiguang repurchased the 53.35% stake in Beijing Wenfeng and Zhonghao Pharmaceutical, and the repurchase price was the equity transfer and the interest on bank loans during the same period.

At the same time, Beijing Wenfeng and Zhonghao Pharmaceutical's net assets as of the end of June 2017 totaled 27.96 million yuan, and in this acquisition, Guanxi Biological's valuation of the two companies totaled 507 million yuan, the acquisition of the city The net rate is 18.12 times.

"revolutionary drugs"

In order to gain a deeper understanding of the "protagonist" in the merger - the new drug phenene mound, the Securities Times e company reporter paid a special visit to the inventor of phenenimod - Dr. Chen Genghui, president of Beijing Wenfeng. According to him, in the early 1990s, during his doctoral studies in Canada, he discovered new broad-spectrum fungicides and other biologically active substances through his symbiotic microbial nematodes and bacteria with his mentor John M. Webster and postdoctoral Li Jianxiong.

Chen Genghui's doctoral thesis is a systematic discussion of this series of discoveries, and obtained the first patent approval in 1996. In December 1999, Chen Genghui and John and Li Jianxiong founded Welichem, a company named after three people, to start their drug development. In 2000, the company began a $1 million venture capital investment; in May 2005, the company was listed on the Toronto Stock Exchange. With the help of capital, the company has entered a new stage of development.

Under the leadership of Chen Genghui, the research and development of new drugs in China has made great progress and has become a major national science and technology project in the “Eleventh Five-Year Plan” and “Twelfth Five-Year Plan”. In 2009, Chen Genghui unloaded the burden of the CEO of the Canadian company, returned to China to focus on the development of China's cause, and established Beijing Wenfeng in cooperation with Hebei Wenfeng.

Also in 2009, phenenimox received clinical trial approvals in China. Chen Genghui said that although the time for obtaining clinical approvals in China is two years later than that of foreign countries, due to China's excellent clinical experimental team, China's project progress is faster than Canada's progress, making it possible for China to launch this kind of first in the world. drug.

Subsequently, the reporter visited Professor Zhang Jianzhong, director of the Department of Dermatology, Peking University People's Hospital, who is the person in charge of the clinical trial of phenenimod. Zhang Jianzhong revealed to reporters that Chen Genghui was initially suspicious when he invited him to lead clinical trials. Because of the incurable and recurring skin disease of eczema, it has been a breakthrough drug for decades. However, clinical trials in subsequent years have confirmed that phenenimolide has high safety, good curative effect, long remission period and low recurrence rate for psoriasis.

Zhang Jianzhong told reporters that it is not easy to find such a compound in nature and to be able to industrialize it step by step to this stage. At the annual meeting of the American Academy of Dermatology in March this year, Zhang Jianzhong reported the results of clinical trials of Chinese phenenables, causing a sensation in the industry.

"Phenenic moody is a revolutionary drug, an epoch-making drug, and a well-deserved First-in-class. This is the inventor's fortune and the gospel of patients." Zhang Jianzhong commented.

Xu Jiaqi, director of the CFDA Drug Evaluation Center, also pointed out that the "12th Five-Year Plan" major special support product phenenimod is a major breakthrough in the field of international psoriasis topical skin treatment for 30 years, which has caused peers in the pharmaceutical industry at home and abroad. Highly concerned, even international industry giants have separately proposed the cooperation or acquisition of benzomethod.

Or welcome billions of market space

According to the person in charge of Guanxi Biological, phenene mound is a new class 1.1 drug in the country. It belongs to the original drug that has not been marketed at home and abroad. There is no new drug listed in the domestic market for psoriasis in the past 30 years. The results of previous clinical trials show that phenemidine is equivalent to improving the overall efficacy of skin lesions and improving the basic cure rate of skin lesions, and is even superior to the similar drug calcipotriol preparation in some indicators, while treating psoriasis. Rapid onset, low recurrence rate, long-term repeated medication safe and effective, better than current international standards.

"The current market for psoriasis is mainly the imported drug calcipotriol, but there are some side effects of long-term use of calcipotriol. The safety is still controversial. The safety of phenene med is better than that of calcipotriol. Because it directly acts on the target of disease, the drug has a fast effect and the remission period is up to 9 months, which is currently not achieved by any topical drug. At the same time, as a small molecule chemical drug, the mass production cost of phenenimox Far less than calcipotriol." The person in charge mentioned above.

In terms of market capacity, there are currently more than 8 million silver shavings and more than 80 million eczema patients in China, and they are increasing year by year. According to data from the US research institute IMS Midas, the global therapeutic market for psoriasis reached US$7.49 billion in 2014, and the market size is expected to reach US$9.02 billion in 2019. Southwest Securities Research Report pointed out that the domestic market for psoriasis is more than 3 billion yuan, and phenene mound is expected to replace other existing varieties and develop into large varieties of more than 1 billion yuan.

The person in charge also revealed that in addition to psoriasis, phenenable has therapeutic effects on various other diseases such as eczema. With further research and development, it is expected to "multi-faceted flowering". In addition, once Benzenemod is approved successfully, it will receive years of patent protection, during which domestic similar generic drugs will not be approved.

Everything is ready for approval

For the crown carp, after the core main products such as brain (ridge) membrane and artificial cornea have been created, phenenimod has become the company's next innovative and high-profile product.

To this end, the company has already begun preparations for the production and sale of benzomethod in advance. According to the above-mentioned person in charge, Zhonghao Pharmaceutical has set up a production capacity and marketing team for benzene modal, and started dermatology marketing work in advance. Now it has initially completed marketing plans such as product positioning, marketing strategy, sales strategy, and pharmaceutical factories. Only after the drug is approved, it will enter GMP certification.

In response to the product positioning of benzomethod, the person in charge said that phenenimod's goal is not only to replace calcipotriol, but to change the patient's awareness of psoriasis. “To this end, we have cooperated with 24 domestic hospitals with the largest number of outpatients in the field of dermatology. Through the promotion and cooperation with well-known hospitals, we can increase the popularity of phenenimod as soon as possible, which is conducive to further academic promotion. ."

The person in charge also pointed out that the 266 million yuan consideration for the acquisition of the equity of the two companies from the controlling shareholder Guangdong Zhiguang seems to have a higher valuation, but in fact only covers the input cost of Guangdong Zhiguang in the early stage. “The controlling shareholder has previously invested a lot of funds and resources for incubating and supporting Beijing Wenfeng. The price of this related party transaction is fair and there is no harm to the interests of small and medium shareholders. From the current progress, we have won this year for benzene meteole. The batch is full of confidence."

Guanxi Biological also pointed out in the announcement that from the perspective of long-term development, this investment can enrich and expand the company's product line, and form new advantageous technologies with potential for development in related new materials and new product technologies. In the future, the company will form a pharmaceutical business and asset layout with regenerative medicine as its core, strive to create a champion single product, form a cascade of innovative product reserves, and form a combination of “innovative heavy products + strong marketing channels”. A new pharmaceutical business model that achieves a distinctive positioning and innovative position in the pharmaceutical industry.

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