\u3000\u3000 Yifan Pharmaceutical Co.Ltd(002019) (002019)
The innovative drug f-627 is expected to be approved for marketing in the United States and Europe, and the clinical progress of ACLF, a new indication of f-652, is smooth
F-627 is a recombinant human granulocyte colony stimulating factor Fc fusion protein (rhG CSF FC) independently developed by Yiyi biology, a holding subsidiary. It is used to treat neutropenia (CIN) caused by chemotherapy. Compared with traditional long-acting rhG CSF, it reduces the production link of PEG connection and is more conducive to quality control.
A number of phase III clinical trials of f-627 in the United States have reached the preset end point. In addition, the “05” trial used by the company for listing declaration reached spa with FDA, indicating that FDA’s approval of the “05” clinical trial scheme and statistical analysis method of clinical results of f-627 will be conducive to the approval of f-627 for listing. The company has completed its listing application in the United States and the European Union and has been accepted. If it is approved to be listed in both places in 2022, it is expected to carry out commercialization activities and contribute revenue. Meanwhile, the company is expected to submit the listing application of f-627 to nmpa in early 2022.
F-627 has been commercialized. On August 30, 2021, the company reached an agreement with Zhengda Tianqing. Zhengda Tianqing will obtain the exclusive authorization for the commercialization of f-627 in China, and Yiyi biology will receive up to 210 million yuan of down payment, milestone payment and graded net sales commission. The sales capacity of Zhengda Tianqing is expected to boost the large volume of f-627.
F-652 is a recombinant human interleukin 22fc fusion protein independently developed by Yiyi biology. It is an innovative drug with new mechanism and FIC potential. At present, there is no similar drug on the market. The newly launched clinical trial of chronic plus acute liver failure (ACLF) is progressing smoothly, and the phase II clinical trial has completed the administration of the first patient. At present, f-652 has carried out a number of clinical trials for indications, including chronic acute liver failure, acute graft-versus-host disease, acute alcoholic hepatitis, covid-19 pneumonia and acute pancreatitis.
Calcium pantothenate ushered in price rise, which is expected to drive performance improvement
Affected by the price rise of upstream raw materials and the dual control of energy consumption, the market price of calcium pantothenate is expected to continue to rise. Due to the price rise of upstream raw materials, tight supply of raw materials and rising costs, the price of calcium pantothenate has continued to rise by more than 140% since the third quarter of 2021. According to health.com, since January 11, Chinese manufacturers of calcium pantothenate have resumed their quotation, with the price of 360 yuan / kg and the export quotation of 50 US yuan / kg, which has increased significantly. The price rise of calcium pantothenate in this round is a rebound at the bottom of the cycle, and the profitability of calcium pantothenate is expected to be greatly improved. Among the major manufacturers, Yifan Pharmaceutical Co.Ltd(002019) has a high global market share and occupies a leading position. The company adopts the market-oriented pricing strategy, superimposes the scale effect of the company’s production capacity, and the net profit is expected to increase significantly.
The sales volume of exclusive varieties of traditional Chinese medicine has increased rapidly, and the innovative drugs of traditional Chinese medicine under research are progressing smoothly
The sales of the company’s own exclusive traditional Chinese medicine varieties have increased rapidly, and the innovative traditional Chinese medicine under research is progressing smoothly. In 2021, the sales volume of Yifan Pharmaceutical Co.Ltd(002019) self owned core products increased greatly, including nearly 5 million dehumidification and antipruritic ointment and more than 6.9 million boxes of Xiaoer Qingqiao granules. It is expected that the exclusive varieties of traditional Chinese medicine will enter a rapid growth stage. Following the western idea of evidence-based medicine, compound Huangdai tablet has carried out a number of clinical trials. In the trials, the sequential treatment of compound Huangdai tablet can shorten the treatment onset time of children with acute promyelocytic leukemia, improve the complete remission rate and prolong the survival time. At the same time, it has good treatment safety. Compound Huangdai tablet can achieve the same curative effect as arsenic trioxide in the treatment of aPL in children. Yifan Pharmaceutical Co.Ltd(002019) Duanjin detoxification capsule, an innovative traditional Chinese medicine under research, was used to prevent drug relapse and won the first prize of the science and technology award of the Ministry of public security. The drug is about to enter phase IIa clinical stage.
Profit forecast and investment rating
Considering the impact on the company’s performance caused by the large price reduction of calcium pantothenate in 2021, the increase in the sales expenses of promoting its own pharmaceutical products and the increase in the related expenses of Yiyi biology, we reduced the company’s revenue in 2021 from 5.311 billion to 4.508 billion yuan and the net profit attributable to the parent company from 503 million yuan to 389 million yuan; Considering that the company is expected to benefit from the listing and sales of innovative drugs and the price rise of calcium pantothenate in 2022, we will increase the revenue from RMB 6.819 billion and RMB 8.238 billion to RMB 6.862 billion and RMB 8.609 billion respectively in 2022 and 2023, and the net profit attributable to the parent company from RMB 808 million and RMB 1.070 billion to RMB 1.043 billion and RMB 1.083 billion respectively; EPS in 2021, 2022 and 2023 are 0.31 yuan, 0.84 yuan and 0.88 yuan respectively. The corresponding current PE is 63, 23 and 23 times respectively, maintaining the company’s “buy” rating.
Risk tip: the approval progress of innovative drugs is delayed, the price rise of calcium carbonate is less than expected, and the drug sales is less than expected
