\u3000\u3 Shengda Resources Co.Ltd(000603) 259 Wuxi Apptec Co.Ltd(603259) )
Events
On March 24, Wuxi Apptec Co.Ltd(603259) announced that the production and QC inspection of GMP level plasmid in Wuxi ATU Wuxi base successfully passed the EU QP certification, marking that the company can provide global customers with high-quality clinical and commercial product production and CMC services, so as to empower global customers and help new drug development.
Brief comment
Wuxi ATU Wuxi base successfully passed the QP audit. The QP system was first introduced into EU GMP in 1975. This system can effectively ensure that personnel at all levels of enterprises perform quality responsibilities and ensure drug quality, and has become one of the cores of EU GMP system. The quality management system, facilities and equipment of Wuxi ATU Wuxi base fully meet the regulatory requirements of EMA and successfully passed the QP audit. The audit lasted for two days. The audit process was in accordance with eudralex Vol 4 (EU GMP) regulations and ICH and other guiding principles. The audit scope covered quality management system, strain library building and management and plasmid production.
Wuxi ATU, creating a new global ctdmo model. As a Wuxi Apptec Co.Ltd(603259) cell and gene therapy business platform, Wuxi ATU has created a unique ctdmo (contract testing, development and production outsourcing service) business model, which can better deal with the problems of high complexity and difficulty in testing, development and release in the current CGT field, and effectively solve the cost of enlarged production. In 2021, the revenue reached 1.03 billion yuan, a year-on-year decrease of 2.8%. Among them, the revenue of Chinese business increased by 87% year-on-year, which partially alleviated the impact of the decline of American business. It is expected to enter the accelerated rise cycle in 2022.
Abundant pipeline under research + continuous expansion of production capacity, accelerating development in the future. Wuxi ATU has a rich pipeline under research, 58 preclinical and phase I clinical projects, 5 phase II clinical projects and 11 phase III clinical projects (of which 4 are about to submit listing applications). In addition, the company has continuously strengthened its capacity and capacity building. The bases of Shanghai Lingang Holdings Co.Ltd(600848) with an area of 15300 square meters and Philadelphia with an area of 13000 square meters have been put into operation from October to November 2021 Wuxi Apptec Co.Ltd(603259) as a platform leading enterprise in CXO sector with international competitiveness, it has full newly signed and on-hand orders and strong growth certainty. It is optimistic about the future development potential of the company.
Profit forecast and investment suggestions
We expect the net profit attributable to the parent company from 2022 to 2024 to be RMB 8.019/93.41/11.811 billion, corresponding to 43 / 37 / 30 times of PE respectively, maintaining the “buy” rating.
Risk tips
Covid-19 epidemic aggravation risk, order execution less than expected risk, overseas supervision risk, ban lifting risk, core technical personnel loss risk, IP protection risk, investment risk, exchange rate fluctuation risk, raw material price rise risk, safety production and environmental protection risk.
