Hengrui is standing on a new starting line again.
On the 22nd, Jiangsu Hengrui Medicine Co.Ltd(600276) ( Jiangsu Hengrui Medicine Co.Ltd(600276) . SH) disclosed the annual report of 2021: the company achieved an annual operating revenue of 25.906 billion yuan, a year-on-year decrease of 6.59%; The net profit attributable to the owners of the parent company was 4.53 billion yuan, a year-on-year decrease of 28.41%.
There are two figures worth noting: first, the revenue decreased by 6.59% year-on-year, which is the first year-on-year decrease in revenue since Jiangsu Hengrui Medicine Co.Ltd(600276) its own historical records; Second, the R & D investment of Jiangsu Hengrui Medicine Co.Ltd(600276) reached 6.203 billion yuan, an increase of 24.34% over the previous year, and the proportion of R & D investment in sales revenue reached 23.95%, which also set a new high since Jiangsu Hengrui Medicine Co.Ltd(600276) has its own historical record.
These two sets of data show that affected by the centralized purchase of generic drugs, medical insurance negotiation and other factors, Jiangsu Hengrui Medicine Co.Ltd(600276) performance is under obvious pressure, and the transformation is still in pain; In this regard, Jiangsu Hengrui Medicine Co.Ltd(600276) also gave its own firm strategic choice, that is, to carry out R & D, R & D and R & D resolutely and unswervingly.
In fact, in recent years, Jiangsu Hengrui Medicine Co.Ltd(600276) 's R & D investment has always maintained at about 20%. In the annual report of 2021, Jiangsu Hengrui Medicine Co.Ltd(600276) disclosed more information about R & D benefits.
one year "Shangxin" 9 innovative drugs / new indications
In 2021, China Meheco Group Co.Ltd(600056) industry will face great pressure and challenges. As a "first brother", Hengrui is naturally unavoidable.
After the first decline in annual revenue in 2021, the performance pressure in 2022 continues. According to the quarterly report disclosed on the same day, as of March 31 this year, Jiangsu Hengrui Medicine Co.Ltd(600276) achieved an operating revenue of 5.479 billion yuan and a net profit attributable to shareholders of listed companies of 1.237 billion yuan, a year-on-year decrease of 17.35%.
In response, Jiangsu Hengrui Medicine Co.Ltd(600276) explained: "with the purchase of generic drugs gradually entering the deep-water area, the varieties involved are increasing, and the sales revenue of generic drugs in the company's stock is accelerating to decline. The medical insurance negotiation accelerates the entry of innovative drugs into the medical insurance catalogue, but the sales and profit space are further compressed. In addition, with the increasing homogenization competition of innovative drugs, the development of the company is facing great performance pressure and transformation challenges."
Facing the reality is the first step to challenge Jiangsu Hengrui Medicine Co.Ltd(600276) 's solution is to innovate R & D and hedge these pressures with new increments. Among them, the number of products is the most intuitive way to show the benefits of R & D.
In 2021, Jiangsu Hengrui Medicine Co.Ltd(600276) launched three innovative drugs: haitripopa ethanolamine tablets, proline hengglitazin tablets and darcilil hydroxyethanesulfonate tablets. The number of innovative products approved for listing increased to 10, ranking among the best in the same industry in China.
In addition, in 2021, Jiangsu Hengrui Medicine Co.Ltd(600276) of carrelizumab for injection was approved for listing with four new indications; The innovative drug fluzopari capsule and remazolam toluenesulfonate for injection have one indication approved for marketing respectively.
Since the indications of drugs correspond to different use scenarios, the approval and listing of new indications and new drugs means that Jiangsu Hengrui Medicine Co.Ltd(600276) has continued to expand its "foothold" in the field of innovative drugs. Accordingly, in 2021 alone, Jiangsu Hengrui Medicine Co.Ltd(600276) has completed the construction of nine "footholds", and the innovation speed has always been in the first echelon of the industry.
They are the first acceleration of Hengrui on the new track of innovative medicine in 2021.
In 2021, Hengrui also obtained 10 approval documents for the production of innovative pharmaceutical preparations, 16 approval documents for the production of generic pharmaceutical preparations and 108 clinical approval documents for drugs, obtained approval documents for the consistency evaluation of 16 varieties, completed the application for the consistency evaluation of five products, three clinical trials were included in the list of breakthrough treatments, and five listing applications were given priority.
In addition, Hengrui has prospectively and widely distributed multiple treatment fields, covering a wide range of research fields such as kinase inhibitors, antibody drug conjugates (ADC), tumor immunity, hormone receptor regulation, DNA repair and epigenetics, supportive treatment, etc. in the field of tumor alone, as well as autoimmune diseases, pain management, cardiovascular diseases, metabolic diseases, infectious diseases, respiratory diseases, blood diseases, nervous system diseases, ophthalmology Nuclear medicine and other fields have also been widely distributed.
All these are expected to open a new space for Jiangsu Hengrui Medicine Co.Ltd(600276) in 2022 and subsequent years, which is also the stamina of Jiangsu Hengrui Medicine Co.Ltd(600276) .
set up another battlefield overseas
Jiangsu Hengrui Medicine Co.Ltd(600276) gives the second step of going to sea, which is also the common choice of many pharmaceutical enterprises. Compared with its peers, Hengrui's sea voyage is full of its own characteristics - including the sea voyage of generic drugs and extending the tentacles of innovative research and development overseas.
The advantages of this are obvious: on the one hand, after generic drugs go to sea, the life cycle of drugs can be extended, and new increments can be obtained in overseas markets to further hedge the downward pressure brought by centralized purchase in the Chinese market; At the same time, through the sea of generic drugs, Jiangsu Hengrui Medicine Co.Ltd(600276) can go through the whole process from drug registration and approval to market sales at a low cost, which has completed the "military training" for the follow-up sea of innovative drugs and laid a solid foundation.
Therefore, in 2021, Jiangsu Hengrui Medicine Co.Ltd(600276) first carried out the "platoon" of personnel: Mr. Scott filosi served as the CEO of Hengrui America / Europe and was responsible for the operation and management of Hengrui America and Europe as a whole; Dr. Joseph E. Eid, an expert in the medical field, served as the chief medical officer of Hengrui America / Europe, and was fully responsible for the company's drug development and medical affairs in Europe and America; Dr. Mike Lee and Dr. Kiyoshi hashigami served as deputy general managers of clinical R & D in Hengrui Australia and Hengrui Japan respectively, responsible for establishing clinical R & D teams in both places and promoting and supporting the company's global clinical projects in Australia and Japan.
Secondly, Hengrui accelerated the establishment of "Fortress base" overseas. Hengrui has successively established a complete clinical R & D team covering medical science, clinical operation, registration, pharmacology, statistics, quality management and other departments in the United States and Europe. At present, the company has more than 170 overseas R & D teams, with a total overseas R & D investment of 1.236 billion yuan, accounting for 19.93% of the total R & D investment.
Based on this, in 2021, Jiangsu Hengrui Medicine Co.Ltd(600276) of carmustine for injection was listed in the United States and Australia, 21 registration approvals including injections, oral preparations and inhaled anesthetics were obtained in Europe, America and Japan, and one preparation product was temporarily approved in the United States; A total of preparations and drug registration applications were submitted to the FDA in the United States, and 6 preparations were registered in the United States.
In terms of innovative drugs going to sea, several products under development, such as shr-a1811, ins068, shr-1819 and shr-1707, have successfully realized global synchronous development. There are nearly 20 projects under research carrying out international clinical trials, including 7 International multi center phase III projects.
What is worth mentioning most is Jiangsu Hengrui Medicine Co.Ltd(600276) the first international multicenter phase III clinical study - the international multicenter phase III study of carrelizumab combined with apatinib in the treatment of advanced liver cancer. The project has submitted an application for listing in China, and the project team has also started preparations before the submission of FDA BLA / NDA, which is planned to be submitted in 2022.
Based on this study, carrelizumab for the treatment of advanced hepatocellular carcinoma has obtained the qualification of FDA orphan drug, and is expected to enjoy policy support in the follow-up research and development and commercialization.
Another sign is that Jiangsu Hengrui Medicine Co.Ltd(600276) is frequently participating in various international academic conferences, which is not only a proof of its own R & D ability, but also conducive to establishing a good brand image for Jiangsu Hengrui Medicine Co.Ltd(600276) going to sea and building momentum for subsequent business cooperation and overseas sales.
In terms of data, at the annual meeting of the American Society of Clinical Oncology (ASCO) in 2021, Jiangsu Hengrui Medicine Co.Ltd(600276) a total of 64 studies were selected, including 38 studies of carrelizumab alone, covering 11 cancer species; Many studies such as carrelizumab and darcili have published 28 papers in the lancet, natural medicine and other international top academic journals.
It can be seen that Jiangsu Hengrui Medicine Co.Ltd(600276) , which started in Jiangsu Lianyungang Port Co.Ltd(601008) , has taken the step of transformation. On the one hand, it has invested heavily in research and development, and on the other hand, it has firmly set sail to the sea. Everything has just begun. Seeds will sprout and snowballs will roll bigger and bigger. Yes, this time, Hengrui is on a new starting line, but the difference is that this time, it is not barehanded.
