Hengrui Pharmaceutical (600276): PD-1 monoclonal antibody approved for marketing and subsequent combination is expected to drive further growth

Hengrui Pharmaceutical (600276): PD-1 monoclonal antibody approved for marketing and subsequent combination is expected to drive further growth

Event: Carelizumab obtained conditional approval for listing.

On May 31, 19, the company announced that PD-1 mAb Karelizumab for conditional approval was registered and the indication was “regenerative or refractory classic Hodgkin lymphoma after at least second-line chemotherapy.”tumor”.

Opinion: The company submitted an application for registration of Karelizumab (SHR-1210) on April 18, 2018 and received a replacement. The entire registration approval process took about 13 months. At present, Karelizumab has become any 5th An approved PD-1 monoclonal antibody.

According to CSCO 2018 data, the third-line treatment of Carrelizumab for relapsed or refractory classic Hodgkin’s lymphoma has an ORR of 84.

8%, where CR is 30.

3%, PR is 54.

5%.

Compared with other approved PD-1 mAbs, Karelizumab shows similar long-term efficacy.

According to IMS data, the global PD-1 monoclonal antibody sample in 2018 was approximately 141.

US $ 7.8 billion, with a domestic profit of approximately 643.

750,000 US dollars, the previous PD-1 monoclonal antibody market is still in its infancy, but the development of transfer indications is expected to usher in rapid growth in the future.

The layout of indications for each cancer type is perfect, and the combination of apatinib has significant curative effects: referring to the historical trends of Keytruda and Opdivo, the expansion of large cancer indications on the sales volume of PD-1 mAb may lead to a decisive effect.

CDE data shows that the company is currently carrying out more than 29 Karelizumab (SHR-1210) -related clinical trials, of which the combination with apatinib or chemotherapy has enabled the company to adapt to lung cancer, liver cancer, and gastric cancer indications.Both have achieved outstanding clinical progress.

For non-small cell lung cancer, the first-line treatment plan of carelizumab combined with chemotherapy was designed with reference to Keytruda to improve clinical success rate, and the ORR of second-line treatment with apatinib reached 29.

7%.

For gastric cancer, the first-line treatment ORR of carelizumab combined with chemotherapy combined with apatinib is more than 60%, which is effective in clinical treatment. Phase III clinical trials are currently being combined.

In liver cancer, the clinical data of single-line second-line treatment of carelizumab is similar to that of Keytruda and Opdivo. Currently, it has been declared on the market and is being evaluated by the proposed priority trial. The average ORR of first-line treatment with apatinib or chemotherapy exceeds 40%.The combination of three drugs is worth looking forward to.

With the continuous development of Karelizumab’s indications, while overlapping the company’s strong channel access and commercialization capabilities, the sales of Karelizumab are expected to reach 10 billion US dollars.

R & D expansion continued to grow at a high rate, and innovation R & D entered the harvest period: The company’s R & D expansion continued to grow at a high rate. According to the company’s quarterly report, the company’s R & D investment in 19Q1 was 6.

62 ppm, an increase of 56 in ten years.

57%, revenue from R & D funding is 13.

32%.

After years of high R & D investment, the company has gradually entered the innovation harvest period.

In 2018, the company’s heavy-duty innovative varieties such as thiopefilgrastim, pirlotinib, and albumin paclitaxel have been approved for listing. The approval of carizolizumab this time will help to bring the company’s performance to the next level.

In addition, according to CDE data, the company’s PD-L1 monoclonal antibody SHR-1316 combined with first-line chemotherapy for extensive-stage small cell lung cancer is already in the Phase III clinical trial, and first-line therapy with chemotherapy for esophageal squamous cell carcinoma is also in the Phase II clinical trial.Approved for listing.

Investment recommendation: Overweight-A investment rating, 6-month target price of 70.

80 yuan.

We expect 深圳桑拿网 the company’s revenue growth from 2019 to 2021 to be 29.

1%, 24.

7%, 21.

1%, net profit growth rate was 28.

7%, 24.

9%, 20.

8%, outstanding growth; given Overweight-A investment rating, 6-month target price is 70.

80 yuan, equivalent to a dynamic P / E ratio of 60 in 2019.

Risk warning: product price reduction risk, core product marketing is less than expected, new drug development is less than expected, etc.