Events:
On April 8, 2021, Baiji Shenzhou Guangzhou Biopharmaceutical production Base was officially approved for commercial production and commercial supply.
After this commercial production is approved, Baiji Shenzhou will become the first pharmaceutical company in Guangdong Province to be approved to commercialize the production of anti-PD-1 monoclonal antibodies, and the Guangzhou production base will also become the first pharmaceutical factory in the world to adopt the second commercial production of KuBioTM system.
Comments:
Baiji Shenzhou Guangzhou production Base will have a total production capacity of 64000 litres after it is completed at the end of 2021, with a future maximum of 200,000 liters at the beginning of 2017. Baiji Shenzhou Guangzhou Biopharmaceutical production Base, which has a total investment of 2.2 billion yuan, covers an area of 100000 square meters and does not cooperate with Guangzhou Development Zone, broke ground in Zhongxin Guangzhou knowledge City, where it develops and produces macromolecular biopharmaceuticals on a commercial scale.
Baiji Guangzhou Biopharmaceutical production Base Phase I and event plants have been completed in September 2019 and December 2020 respectively, with a production capacity of 24000 litres of biological agents at present. The planned production capacity of the third phase of the plant is 40,000 litres, and the construction is expected to be completed by the end of 2021. Upon completion, the total production capacity will reach 64000 litres. In the future, the production capacity of Guangzhou production base is expected to exceed 120000 liters, with a maximum of 200000 liters.
The company's macromolecule production base is expected to help the company to control the core varieties in its own hands. From the development path of Pfizer, Merck Shadong, GSK and other Big Pharma, multinational giants generally have perfect R & D and production systems. Although they will adopt the contract manufacturing mode of CRO and CDMO, the control of core products must be in their own hands. Baiji China is expected to better meet its own production needs in the future by sparing no effort to build its own production capacity.
The construction of the company's macromolecular production base shows the confidence of the company's development the side effect of capacity construction is secondary overcapacity, especially when the commercial performance of products is poor, the phenomenon of capacity waste is even more serious. However, we believe that judging from Baiji's current pipeline products in China, the company has rich products and high volume expectations in the future, and the construction of potential production capacity is an exquisite upper-hand move.
With the release of domestic health insurance for Reilizu McAb and the global sea, the demand for production capacity will further increase in the future. Focusing on China, at the end of 2020, the indications of relapse and refractory classical Hodgkin's lymphoid tumor ((cHL)) and urothelial cancer ((UC)) of tirelizumab will be included in the national health insurance catalogue, which is expected to achieve volume-for-price and further increase sales. Look at the world, take a firm step on the road to sea for Raleizhu monoclonal antibody. In January 2021, Baiji Shenzhou Buenohua reached an authorized cooperation of US $2.2 billion for the non-commercial development and production of tirelizumab in many countries; in addition, tirelizumab is the first to carry out overseas clinical trials and has the largest number of domestic clinical trials in the world, a total of 15 registered clinical trials have been carried out worldwide.
The harvest of innovative varieties in the field of oncology and autoimmune diseases is just around the corner. In addition to PD-1 products, the Blincyto introduced by Amgen has been conditionally approved by NMPA in December 2020; the BLA of Sylvant (Stuximab) and Qarziba (Dituximab) introduced by EUSA has been approved and reviewed by NMPA in November 2020 and January 2021 respectively, and is expected to be listed and commercialized in 2021. In addition, the company's early R & D pipeline layout TIGIT, TIM-3, OX40, PI3K δ, HPK1 and other novel target development projects are progressing smoothly, and the demand for small-scale and pilot-scale tests is expected to increase gradually. With the landing of potential production capacity, we believe that the company's self-built macromolecular production base will provide a continuous driving force for the continuous expansion of the company's product matrix and continuous innovation.
Profit forecast
As the company's Guangzhou biopharmaceutical production base has been approved for commercialization, the future R & D and commercialization of macromolecular products have been formally integrated.
At present, the company's commercial varieties of zebutini and tirelizumab are progressing smoothly. The, License in cooperative products will be put on the market soon, the products will continue to go out to sea, and there is great potential for early research and development of pipeline targets. Although the company is still in a state of two losses, but with the further enrichment of the product pipeline, the company's performance is about to improve. It is estimated that the company's revenue from 2021 to 2022 will be $11.14 and $1.462 billion, respectively, and its net profit will be-13.62 and-932 million respectively, and its EPS will be-0.93 and-0.78 respectively. In the future, with the continuous landing of the company's R & D pipeline products, it is expected that the company's performance will gradually improve, covering for the first time and giving an overweight rating.
Risk hint
The risk of drug research and development, the risk of drug price reduction, and the risk of intensified competition.