Indian innovative medicine enters the overseas market with a variety of operating models
India’s innovative drugs enter the overseas market. There are currently the following models. First, clinical research is carried out, and sales teams are established to be responsible for the promotion of overseas markets.Transfer, obtaining sales sharing, representing Yifan Medicine and Hetao Medicine; 3. Third, in the early stage of innovative drug research, it has achieved foreign authorization, jointly carried out clinical research with the partners, and was responsible for sales by the partners. The representative was a legendary creature.4. Through part of the equity of the cooperative company and the ownership of the product, if the product will be authorized to be authorized to the global pharmaceutical leader in the future, the company can obtain the value of the value, representing Hengrui Pharmaceutical.
The space and pricing of the American innovation medicine market are better, and it has become an important direction for going out to the sea
According to Shalvin’s data, the total size of the global pharmaceutical market in 2022 was 1495 billion US dollars, which were divided by the country and region. Among them, the United States accounted for 39.72%, India was 15.44%, and the five European countries (Britain, France, Germany, Spain, and Italy) Total 12.63%. The United States is still the main market of global innovative drugs and an important direction for domestic innovative drugs to go to sea.Because the US medical insurance system is mainly commercial insurance, drug pricing is high.Data from the top 25 best -selling drugs in the world show that the average price of American drugs is significantly higher than that of other global countries, about 4 times that of European countries and 5 times that of Japan.Taking the three domestic innovative drugs that have been approved by the FDA in the United States as an example, Zabbutinib is priced at more than 10 times that in the Indian market in the US market, and Tripley has more than 30 times.
Ono Pharmaceutical Restart: 2014-2023 Fiscal year’s performance rapidly growing
Nawuli Mipida (product name: OPDIVO ®) is an PD-1 immunoaged checkpoint inhibitor. It was originally developed by American biotechnology company Medarex and Japanese Ono Pharmaceutical in 2005.In 2009, BMS completed the acquisition of Medarex, and the ownership of Nawuli Mippitarian also transferred to BMS accordingly. At present, the relevant patent rights of Nawli Mippitaria are jointly owned by BMS and Ono Pharmaceutical.Nawli Ulitab was the first to be approved in Japan in July 2014. It is the first PD-1 monoclonal anti-anti-resistance approved in the world. The treatment of adaptive is melanoma.At the end of 2014, Nawuliyu was resisted by the US FDA approved listing.Japan’s Ono Pharmaceutical reached a cooperation agreement with BMS in 2011 to award the right to develop and commercialize the BMS globally (except in Japan, South Korea, and India and Taiwan.In July 2014, Ono Pharmaceutical and BMS further expanded the strategic cooperation agreements between the two sides, and jointly developed and commercialized a variety of immunotherapy (as single drugs and joint treatment programs) in Japan, South Korea, and India and Taiwan.At the same time, Ono Pharmaceutical and BMS agreements, in Japan, South Korea, and India and Taiwan markets, Ru Na Wuli is approved to be listed for sale. Ono Pharmaceutical is expected to obtain a certain percentage of sales in accordance with product sales revenue (4%in North America,Other areas are 15%).At the same time, according to the patent dispute and reconciliation agreement with Merck, Merhado needs to be divided into a certain proportion of Ono Pharmaceutical based on Keytruda’s sales.New Delhi Stock Exchange
Ono Pharmaceutical Rejuvenation: Catalysis and sales of core product events play a decisive role in market value and valuation
From the perspective of stock prices and valuation performance, from 2011 to 2014, with the advancement of the clinical trials of Nawuliyu, successive listing in Japan and other regions, and subsequent adaptive symptoms, the market’s expectations for the sharing income of Ono Pharmaceuticals to share revenue amountContinuous increase has driven the stock price of Ono Pharmaceutical to continue to rise sharply.From 2014 to 2016, Nawuli Ulitaba was in the rapid volume after listing, and the price of Ono Pharmaceutical stocks still increased significantly.In August 2016, NSCLC clinical research failed in the advanced NSCLC clinical study of PD-L1 positive expression (PD-L1 ≥ 5%) in the first-line single-medicine treatment, which led to the market’s expected expected peak of Nawelu’s subsequent sales.With the slowdown of subsequent sales growth, especially sales have gradually been overtaken by Keytruda®, the stock price and valuation of Ono Pharmaceutical fell sharply after 2016.As the overall sales of Nawuli Mipida still maintained a growth trend, as the sales of sales income increased, the income and profit of Ono Pharmaceutical continued to increase. HoweverThe value continues to fall, and the stock price is overall.
Coron Botai: SKB264 is in the world’s first echelon of Trop2 ADC drugs
TROP2 (human nourishing cell surface antigen 2) is a kind of cross -cell membrane calcium signal transduction protein, in BC (breast cancer), NSCLC (non -small cell lung cancer), GC (gastric cancer) and OC (ovarian cancer)Excessive expression and tumor invasion, progress and metastasis.Due to the excessive expression of TROP2 in a variety of tumors, the low expression of normal cells is expected to become a potential anti -cancer drug target.ADC drugs are moving significantly in various drugs/therapies developed around Trop2 targets.In April 2020, the US FDA approved Geely’s injection Trodelvy® to be available. The approved indications were: (1) the local or metastatic Sanyin breast cancer that had been treated at least in the past; (2) Local advanced or metastatic urinary epithelial cancer; (3) HR+/HER2-local advanced or metastatic breast cancer patients who have received endocrine therapy and received ≥2 system treatment (for metastatic diseases)EssenceIn June 2022, my country NMPA approved the listing of TRODELVY® to shoot, and the indications were local or metastatic Sanyin breast cancer.At present, Goshbuke is the only ADC drug that is approved for listing. The progress of SKB264 of Coronboita and the DS-1062 of Astrikon is in the first echelon developed by Trop2 ADC drugs.Essence
Yifan Pharmaceutical: Abergs Pavilion α injection is the first third-generation G-CSF in the world. It has a significant advantage in terms of efficacy and safety.
On November 17, 2023, EVIVE BIOTECHNOLOGY (Billionthon) Evive Biotechnology (Billians) α injection (product name Ryzneuta®) was approved by the US FDA for adult non -medulical malignant tumors.When receiving the treatment of bone marrow inhibitory anticancer drugs that are likely to cause fever neutrophils, the incidence of infection is reduced by the fever neutrophil -reduced infection.Abergs Pavilion α injection is a new type of biological products developed based on the treatment of DI-KineTM biomatole technology platforms with independent intellectual property rights.It has long -term and powerful biological characteristics.Aberg Setting α injection is the world’s first third-generation G-CSF. Compared with the first and second-generation drugs, it has significant advantages in terms of efficacy and safety.In addition to Aberg Setting α injection, there are 8 types of long-term G-CSF approved by the US FDA as of October 2023, of which the innovative drugs are AMGEN PEGFILGRASTIM (Neulasta®) and Spectrum Pharmas, the remaining 6Similar biosiminations planted PEGFILGRASTIM.
Heya Medicine: Sliminib sales in the United States have grown rapidly
Slutinib is a small molecular vascular generator inhibitor with a small molecular molecular vascular type. The main target is the VEGFR kinase family (VEGFR1, 2 and 3).The proliferation, migration and lumen formation of vascular endothelial cells inhibit the formation of new blood vessels in tumor, and finally play the effect of tumor growth inhibitory.Slitinib was approved in China in September 2018. The indication was chemotherapy based on fluoriduroraphine, Osarin, and Ilidan, as well as the growth factors of antibodies endothelial.(VEGF) patients with metastatic colon cancer (MCRC) patients with metastatic colon cancer (EGFR) treatment (EGFR), and entered medical insurance in November 2019.In recent years, Setinib has gradually become a leader in the field of three -tier colorectal cancer. Sales have increased year by year, and the market share has continued to increase.In January 2023, He Huang Pharmaceutical granted the development and commercial rights of chiminib outside India to Takeda Pharmaceutical, and Huang Pharmaceutical will receive a total of 1.13 billion US dollars, including the agreement of $ 400 million when the agreement is completed.The down payment, as well as potential regulatory registration, development and commercial sales milestone payment, and plus the fees based on net sales -based concession.In November and June 2024, the US FDA and the European Union were successively approved to be listed on the market, and Japan’s NDA was still applying.In recent years, the only innovative targeting therapy for the treatment of metastatic colorectal cancer has been approved in recent years. After listing in the United States, it was quickly included in the NCCN guide. The sales amount achieved rapid growth.Quarterly sales exceeded $ 50 million.At present, there are still many indications in Satinib in different research stages. After approval, it is expected to further increase the peak of potential sales.
ASKB589 is expected
Biotechnology is a biological preparation that is highly similar to its original product, but there is no difference in quality, safety and effectiveness.Due to the higher complexity of the molecular structure and production process, compared with chemical generic drugs, the approval approval of biomedical drug supervision is more complicated.After the action mechanism, PK, PD, validity, safety and immunogenicity are not different from the original drug, biological similar drugs can be pushed for adaptation. ThereforeHelps reduce the burden on medical expenses.The use of biological medicines is different in different countries and regions in the United States, Europe.In September 2022, an expert in the EU Biotechnology Working Group (BMWP) and the head of the pharmaceutical institution (HMA) drafted a joint statement that confirmed that the biological similar drugs were approved by the EU (EU).Similar biosiminations.The joint statement pointed out that the biological similar drug approved by the European Union is exchanged, which means that the similar drug can be used to replace its reference preparation, or a biological similar medicineSimilar medicines replaced.Previously, many EU member states have already begun to implement biological similar drugs. This joint statement clarifies the position of EU regulatory agencies, which will help the improving the penetration rate of biological similar drugs in the European Union.The US FDA is more stringent for the use of biological drugs. Manufacturers must submit an application and provide sufficient information in the application to support its interchangeability so that its products can be approved to become exchanged biological drugs that can be replaced.Only patients with medicines in pharmacies can be converted between brand biological agents and exchanges.
The European biopharmaceutical market started earlier, but the number of varieties in the United States increased rapidly
In 2020, the sales amount of biological similar drugs in Europe is greater than the United States. We believe that it is mainly due to Europe as early as 2006 that the first biological similar medicine was approved as early as 2006. The United States did not approve the first biological drug until 2015.The market has the advantage of first -mover.However, from the perspective of the approval rhythm of products in recent years, the US market has shown a trend of catching up.Statistics from the first year of biological similar medicines, the number of similar biomines approved in Europe after 8 years is 15, while the total number of biomedicine -like medicines approved in the United States is 39.We believe that with the increase in the number of products obtained and the patent of biological innovation drugs has expired, the American biological pharmaceutical market has greatly increased its growth potential.
Kexing Pharmaceutical: The product pipeline continues to be rich, and the income of overseas business is expected to enter the stage of rapid growth stage
After nearly 20 years of development, the overseas business of Kexing Pharmaceutical has established a relatively complete overseas business system. It has accumulated rich resources and commercialization in overseas product registration, overseas development and marketing, and overseas GMP compliance audit. It has passed Brazil, Philippine, Indonesia and other about 40 countries and regions have market access and sales. The sales network has 100%of emerging countries with a population of over 100 million
field.Since 2023, the company’s products have been introduced into the fast lane. So far, 13 products have been introduced, covering the fields of anti -tumor, autoimmune, metabolism and other treatment fields. Cooperators have many domestic well -known domestic medical leading companies such as Zhengda Tianqing and Tonghua Dongbao.It shows that the company’s ability to go to sea has been fully recognized by the industry.In May 2024, the company issued an equity incentive plan, with the company’s overseas sales revenue as the performance base in 2023. The overseas sales revenue of each assessment year is determined by the growth rate of the performance base or the cumulative number of overseas registration approval.Higher.In recent years, the company’s overseas income is relatively stable, mainly contributed by the existing variety. As the company introduces the rich product pipeline and gradually completes the market access, we expect the company’s overseas business income to enter the rapid growth stage.
This is the report of the report of the report, and the original PDF original text:Jaipur Investment
"Pharmaceutical and Bio-Pharmaceutical Industry Deep Report: New Starting Point, New Breakthrough-Pioneer Securities [Wang Bin] -20240813 [p. 52]"
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