Fosun Pharma (600196) Company Review: Innovative R & D Platform Reports Production of the First Domestic Trastuzumab Biosimilar
Investment Highlights Event: On April 25, 2019, the company announced that its holding subsidiaries Shanghai Fuhong Hanlin Biotechnology Co., Ltd. and Shanghai Fuhong Hanlin Biopharmaceutical Co., Ltd. developed trastuzumab for injection (biosimilar,That is, the recombinant anti-HER2 humanized transformed antibody for injection) was awarded a trial copy of the drug registration trademark review of the State Drug Administration, with the replacement number being CXSS1900021.
Opinions: The innovation research and development platform has successively made efforts to report the first domestic biosimilar drug of trastuzumab.
Trastuzumab is an anti-HER2 humanized recombinant antibody researched by Roche (Gene Tektronix). It is mainly used to treat breast cancer with HER2 overexpression, metastatic gastric cancer or gastroesophageal junction adenocarcinoma.
It went on sale in the United States on September 25, 1998 and was approved by the country in September 2002 under the trade name Herceptin / Herceptin.
As the world’s first targeted HER2 antibody, trastuzumab is the core of the positive control treatment plan for HER2 in breast cancer diagnosis and treatment guidelines. It is the first-line treatment for relapsed and metastatic advanced diabetes, adjuvant therapy for surgical treatment, and neoadjuvant therapy for breast cancer before surgery.And metastatic gastric cancer.
Global sales revenue for 2018 71.
3.8 billion US dollars, is the top 10 major biopharmaceutical products sold.
Due to price, trastuzumab has a penetration rate of only 25 in China.
About 6%, the stock penetration rate is less than 5%, and there is a big gap between the level ratio of more than 65% abroad.
The original research Herceptin entered the medical insurance catalog in 2017 at a price of 110,000 per person per year, and then quickly increased its volume.
In 2018, the number in China reached 2.7 billion; data from sample hospitals show that the growth rate of trastuzumab sales in Q1-Q3 single quarter of 2018 reached 164%, 139% and 326%, respectively; the third quarter single-quarter salesThe growth rate reached 75%.
We believe that the company HLX02, as a biosimilar of trastuzumab, directly enjoys the same generic name substitute, will become an affordable alternative medicine for patients with related diseases in the country, and promote the sharing of the large market after listing.
At present, the domestic companies that report trastuzumab and HER2 supplemented monoclonal antibodies 深圳spa会所 are only Sansheng Pharmaceutical and Fuhong Hanlin, and then about 5 companies are in clinical phase III.
Fuhong Hanlin is the first domestic trastuzumab biosimilar to be reported for replacement; Sansheng Pharmaceutical’s recombinant anti-HER2 humanized replacement antibody for injection was reported for replacement in September 2018 and is currently under review and approval.
The three major varieties of rituximab, adalimumab and trastuzumab biosimilars have been prominently launched in 2019, and the pharmaceutical industry sector has ushered in structural upgrades.
After years of investment in the company’s biosimilar drug research and development platform, the company enters the harvest period every year. In February, the first rituximab biosimilar drug was approved for marketing. It is expected to be officially commercialized 北京养生会所 in April-May;Biosimilars are reported to produce alternatives and have entered priority review. In April, trastuzumab biosimilars were reported to be produced and replaced. We expect that these two varieties will tend to be approved for listing in 2019-2020.The business income structure is gradually upgrading from chemical generics to biosimilars, and ushering in new growth points.
Earnings forecast and investment advice: We expect operating income to be 291 in 2019-2021.
13 ppm, 359.
53 ppm, 429.
16 ppm, an increase of 16 in ten years.
37%; net profit attributable to mothers is 34.
8.1 billion, 43.
2.7 billion and 54.
6.4 billion, an annual increase of 28.
28%; corresponding EPS is 1.
69 and 2.
The company is one of the domestic leading companies in innovative medicines. The main business has a relatively stable growth and is estimated to be cheap. Starting from 2019, innovative medicines will gradually enter the harvest period and maintain a “buy” rating.
Risk reminders: Outward M & A is not up to expectations; risk of failure of new drug R & D; risk of declining volume and scope of chemical generic drug purchases exceeding expectations.