But the PK drug king, Xiumeile, a new drug for psoriasis, has been approved for marketing, and the domestic same case sold for only 30 million yuan. It was once praised as the "diamond standard" in this field...

The Chinese pharmaceutical field has long been eager for FIC, but when we discover FIC, how will we face it?

If the FDA hadn't approved the drug, this FIC drug with deep roots in China might have been forgotten in the long history of drug developme.

On May 25, Deravant Sciences announced that its Vtama (1% tapinarof, once daily) cream was approved by the FDA for the topical treatment of adult patients with plaque psorias.

This is the first topical new molecular entity approved for the treatment of psoriasis in the United States in 25 years and represents an innovative, non-steroidal type of topical thera.

This drug has a more resounding title in China as "the world's first national class 1 new dru.

In 2020, the product will be included in the medical insurance catalog.

01The first global FIC listed in China

Benvimod is a stilbene-like small molecule compound isolated from a symbiotic bacterial metabolite of a soil nemato.

It is understood that the product patent is jointly held by Chen Genghui, Li Jianxiong and John MWester, Chen Genghui's mentor when he was studying in Cana.

In 2011, with the conclusion of the Phase II clinical trial of Benvimod, its clinical advantages have attracted many multinational pharmaceutical companies to bid for .

It is understood that Benvimod had completed Phase IIb clinical trials in China at that time, and was a major national new drug creation project during the "Eleventh Five-Year Plan" and "Twelfth Five-Year Pla.

On July 13, 2018, GSK sold its interest in Benvimode to Dermavant for $330 milli.

In May 2019, Benvimod was approved for marketing in China through the priority review and approval process for the topical treatment of mild to moderately stable psoriasis vulgaris (mainly plaque psoriasis) in adul.

Regarding why the product can be prioritized in China, Chen Genghui said in an interview with the media that the first is that China's dermatology department has a high clinical level; the second is that there are a large number of patients in China, which can successfully and quickly achieve patient recruitment; the third is that Supported by the national pharmaceutical innovation policy, the product has been continuously supported by the National Science and Technology Major Project of the "Eleventh Five-Year Plan", "Twelfth Five-Year Plan" and "Major New Drug Creation" during the research and development process, and has also obtained priority review and approv.

02 FIC in China

In the field of psoriasis that Benvimode targets, it is a market with many patients and frequent blockbuste.

At present, there are about 420 million people in the world suffering from skin diseases, and the number of patients will continue to increase, and the age will be getting younger and young.

For psoriasis, MNC has been fully deployed and has achieved a l.

Novartis's first fully human interleukin-17A inhibitor, secukinumab (Kexantine), will have sales of US$718 billion in 202 EvaluatePharma previously predicted that global sales of secukinumab will exceed $5 billion in 202

But looking at the situation of Benvimode in the country can not help but feel emoti.

In 2012, the market rights of mainland China, Taiwan, Macau and Hong Kong, which were won for US$10 million, do not seem to be selling well in the domestic market tod.

The domestic marketing license holder of Benvimod, and the parent company of Guangzhou Zhonghao Pharmaceutical .

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is Guanhao Biolo.

It is worth noting that Guanhao pledged its 50256% equity in Beijing Wenfeng and 50256% equity in Zhonghao Pharmaceutical to Industrial and Commercial Bank of China .

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Guangzhou Tianpingjia Sub-branch respective.

Guanhao Bio is a company mainly engaged in medical device busine.

The data shows that in 2021, the company's medical device revenue will account for 87
In its pharmaceutical sector, there is only one listed product of Benvimod, and its holding subsidiaries Beijing Wenfeng and Zhonghao Pharmaceutical have the independent intellectual property rights of a class 1 new drug, Benvimod, in Greater Chi.

In 2020, the sales of Benweimod will be 4758 million yu.

After the product enters the medical insurance in 2021, the revenue of this product will not increase but will decrea.

The revenue will be 293 million yuan, accounting for 12% of the reven.

However, it has achieved a substantial increase in the number of sal.

In 2020, the product will sell 100,000 units, and in 2021, it will sell nearly 400,000 uni.

The total sales of the product after the listing is less than 100 million yu.

For the development of Benvimod, according to the 2021 annual report of Guanhao Bio, there are two new studies with new indications, one of which is an indication for ecze.

te.

The other was a preclinical study of Benvimod in ulcerative colit.

In addition, there is a process optimization study for Benvimod cream, which has been approved by the C.

In terms of research and development, Guanhao Bio will invest 41762 million yuan in research and development in 2021, an increase of 435% over the same period of the previous year, and the number of research and development personnel will decrease by 126% in 2021 to only 70 peop.

This is far from the R&D investment of hundreds of millions, or even tens of billions, of pharmaceutical compani.

Currently, only three original innovative drugs in China have been approved by overseas regulatory agenci.

One of the most representative is Chidamide, the world's first subtype-selective histone deacetylase (HDAC) inhibit.

In 2006, Microchip transferred Chidamide to Huya Bio for $28 million in global patents other than Chi.

In 2013, this small molecule anticancer drug was approved in China for peripheral T-cell lymphoma, and later expanded to breast canc.

Until June 2021, Chidamide was approved by the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan as a monotherapy for the treatment of relapsed or refractory peripheral T-cell lympho.

However, in terms of commercialization, Chidamide has been listed in China for 6 years, and its cumulative sales have just exceeded 2 billion yu.

Back to Benvimode, will Guanhao Biotech show the enthusiasm of MNC to build a blockbuster, invest manpower and financial resources to further research, tap the indication potential of this product, and vigorously expand the existing commercialization market Space, let this so-called "the world's first national class 1 new drug" have more beautiful market data, we will wait and s.

At present, whether the approval of similar overseas products will boost the performance of the product in the domestic market, we still do not know, but what can be seen at present is that the share price of Guanhao Bio has risen sharply by 47% on May 2