Recently, Shanghai Junshi Biosciences Co.Ltd(688180) and Maiwei biology jointly announced that the adalimumab injection (trade name: junmaikang) jointly developed by the two sides has been officially approved by the State Drug Administration (nmpa) for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis.
Adalimumab was originally developed by Alberta and is TNF- α Monoclonal antibody was first listed in the United States in 2002 and entered the Chinese market in 2010. Its trade name is "xiumeile". After the adjustment of the medical insurance catalogue in 2021, the 8 indications approved by xiumeile in China have been covered by medical insurance.
With the expiration of xiumeile's core patents in the United States and Europe in 2016, a number of adalimumab biological analogues have been approved for listing outside China. In 2019, Bio-Thera Solutions Ltd(688177) the first adalimumab biological analogue was approved, and then Zhejiang Hisun Pharmaceutical Co.Ltd(600267) , Xinda biology, Fuhong Hanlin and adalimumab biological analogue of China biopharmaceutical were approved successively.
At present, adalimumab biological analogues in China can be said to be a "Red Sea". When talking about the market competition pattern of adalimumab, some pharmaceutical analysts believe that the high treatment cost is the fundamental reason for the low penetration of the original drug in China, while biological similar drugs have obvious price advantages. It is expected that with the listing of more and more adalimumab biological analogues, the penetration rate of adalimumab in the Chinese market will increase rapidly, and the market scale is expected to increase rapidly.
highly concerned "medicine king"
According to the National Institutes of Health (NIH), more than 80 autoimmune diseases have been identified. The pathogenesis of autoimmune diseases has not been thoroughly studied, and the incidence rate of women is higher than that of men. The main autoimmune diseases include rheumatoid arthritis, ankylosing spondylitis, psoriasis and Crohn's disease. There are about 14.7-23.5 million patients with autoimmune diseases in the United States, accounting for about 8% of the total population.
Once the disease occurs, the patient needs long-term medication. In the international market, autoimmune diseases are the second largest treatment field after cancer, but the Chinese market is far from open. According to China Industrial Securities Co.Ltd(601377) Research Report, the global sales scale of autoimmune and inflammatory drugs will be about 94 billion US dollars in 2020.
When it comes to the autoimmune disease market, we have to mention adalimumab, a star product originally developed by Alberto and with the trade name of "xiumeile". TNF- α It plays a central role in the occurrence and development of a variety of inflammation. It has been proved that a variety of autoimmune diseases such as rheumatoid arthritis, psoriasis, Crohn's disease and ankylosing spondylitis are associated with TNF- α Closely related. Adalimumab as a whole human anti-tumor necrosis factor ɑ (TNF- ɑ) Monoclonal antibodies can specifically interact with soluble human TNF- ɑ It can effectively block TNF by binding and blocking its interaction with TNF receptors p55 and p75 on the cell surface- ɑ Inflammatory effect of.
Xiumeile was first listed in the United States in 2003 and entered the Chinese market in 2010. At present, it has been listed in more than 90 countries around the world. Since its listing, the approved treatment fields in the world involve 17 diseases such as rheumatoid arthritis, ankylosing spondylitis, psoriasis (including plaque psoriasis in children), psoriatic arthritis, juvenile idiopathic arthritis, Crohn's disease (including Crohn's disease in children), ulcerative colitis, suppurative sweat gland inflammation and uveitis.
Thanks to the effectiveness and safety of its drugs, xiumeile's global sales in 2018 were US $20.5 billion, and ranked first in the world's best-selling drugs for seven consecutive years. It is known as the "drug king" in the industry. According to the 2021 performance report released by Alberta, Alberta's total revenue in 2021 was $56.197 billion, a year-on-year increase of 22.7%. Among them, xiumeile also continued to break through the US $20 billion mark, achieving a sales revenue of US $20.694 billion, a year-on-year increase of 3.5%.
However, in the Chinese market, xiumeile's performance before entering medical insurance is not ideal. According to the data of PDB drug comprehensive database, although the clinical demand of Chinese patients is large, due to insufficient medical insurance coverage and high price in the early stage, it will cost more than 200000 yuan per year (7800 yuan / piece, one piece every two weeks). It was not until the 83% reduction of xiumeile was included in the national medical insurance catalogue (class B) in 2019 that it was able to expand rapidly. In 2020, the in-hospital sales of xiumeile in China increased by 614%. After the adjustment of the medical insurance catalogue in 2021, the eight indications approved by xiumeile in China have been covered by medical insurance, and the performance has achieved leapfrog growth. The in-hospital sales increased from 1011141 million yuan in 2020 to 1877484 million yuan in 2021.
However, the drug patent of xiumeile will expire in 2023, which will also bring about the market adjustment of adalimumab. According to the investment report issued by Hong Kong stock 18a biotechnology company, with the promotion of innovative research and development of biological drugs, China's autoimmune disease drug biological agent market is growing rapidly. Autoimmune disease biological agents will replace small molecule targeted drugs as the main treatment in the field of autoimmune diseases and continue to gain market share.
local pharmaceutical enterprises compete
With the arrival of the patent period of the original drug, the market of adalimumab biological analogues in China has been full of smoke.
With the approval of China's first adalimumab biological analogue developed by Bio-Thera Solutions Ltd(688177) in 2019, Zhejiang Hisun Pharmaceutical Co.Ltd(600267) , Xinda biology, Fuhong Hanlin, Zhengda Tianqing, China biopharmaceutical, Sinocelltech Group Limited(688520) , Shanghai Junshi Biosciences Co.Ltd(688180) .
According to the statistics of toubao Research Institute, from 2016 to 2020, the market scale of China's autoimmune disease drug industry increased from US $1.6 billion to US $2.9 billion, with a compound annual growth rate of 16.0%. In the next five years, the diagnosis of autoimmune diseases will be gradually improved, the demand gap of patients will be gradually filled, the increase of patients with autoimmune diseases and the continuous improvement of drug accessibility driven by policies will become the main reasons for the expansion of the market scale of the industry.
In addition, according to China business intelligence data, it is expected that with the listing of adalimumab biological analogues, the penetration rate of adalimumab in the Chinese market will increase rapidly, and the market scale is expected to increase rapidly. It is expected to reach 4.7 billion yuan in 2023, with an annual compound growth rate of 291.4% from 2019 to 2023, and 11.5 billion yuan in 2030, with an annual compound growth rate of 13.7% from 2023 to 2030P align = "center" source: Sullivan, cheetah Institute
It can also be seen from the existing financial reports that adalimumab does "absorb gold" and has also brought bright benefits to local pharmaceutical enterprises. On January 27, Bio-Thera Solutions Ltd(688177) released the performance forecast for 2021.
In 2021, compared with the same period of the previous year, it is expected to turn losses into profits, with net profit attributable to the parent company ranging from 65 million yuan to 95 million yuan and net profit deducted from non net profit ranging from 27 million yuan to 40 million yuan. Among them, the sales volume of gelolib (adalimumab injection) has gradually increased, and the sales revenue is expected to increase by 110 million yuan to 130 million yuan compared with the same period of last year, with a year-on-year increase of 60.15% - 71.09%.
On the commercialization layout of adalimumab, Fuhong Hanlin is also making efforts. On February 23, Fuhong Hanlin announced that it had signed a license and supply agreement with Getz Pharma, granting it the rights and interests of commercialization of adalimumab in 11 countries such as Pakistan, the Philippines, Vietnam, Myanmar, Cambodia and Ukraine and any other mutually agreed regions.
According to insight data, the current penetration rate of biological agents in emerging market countries is low. For example, rheumatoid arthritis drugs still use traditional anti rheumatic drugs (DMARDs) as the main treatment, and the treatment demand is far from being met. The total population of the signing area is about 840 million, and there is a large demand for adalimumab. Fuhong Hanlin adalimumab is expected to further increase its overseas market share.
This time, the adalimumab biological analogues of Shanghai Junshi Biosciences Co.Ltd(688180) / Maiwei biology were approved for listing, which means that the market competition of adalimumab will be further intensified.
According to Shanghai Junshi Biosciences Co.Ltd(688180) public information, the company is anti TNF- α MAb ubp1211 is a biological analogue of adalimumab developed in cooperation with Taikang biology, a wholly-owned subsidiary of Maiwei biology. It is intended to treat autoimmune diseases including rheumatoid arthritis. Phase 1 and phase 3 studies were conducted on ubp1211, Shanghai Junshi Biosciences Co.Ltd(688180) to compare the similarity between the product and the original drug in the treatment of patients with moderate to severe rheumatoid arthritis. The comparative study of physical and chemical structure and biological function shows that ubp1211 has structural similarity and comparable function with the original drug, indicating that ubp1211 has similar efficacy, safety and immunogenicity with the original drug.
As the Shanghai Junshi Biosciences Co.Ltd(688180) third commercialized product after tuoyi (treprizumab) and etsuzumab, the market performance of adalimumab has become a topic of concern in the industry. In the "Star" product field of adalimumab, whether local pharmaceutical enterprises can obtain better market performance in the competition with "drug king" xiumeile in the future, It has also attracted the attention of the industry.
