Author: Hui Yi Yao glycopyrrolate little urchin

At the beginning of the new year, Sansheng Pharmaceutical (01530.HK) issued a heavy news, and it reached a cooperation agreement with global biopharmaceutical giant Samsung Bioepis, which will be Samsung in mainland China (excluding Hong Kong, Macau and Taiwan). Bioepis has developed and commercialized a number of biosimilar drugs in research, including biosimilars of bevacizumab in research product SB8.

In recent years, the marriage of Chinese and foreign pharmaceutical giants is not uncommon in the industry. Under the influence of a series of medical incidents, the trust of Chinese people in domestic brands and the localization challenges of multinational pharmaceutical companies in China, the combination of "Chinese and Western" Strong cooperation has become a good choice for leading pharmaceutical companies to seek complementary advantages and achieve win-win results. With the soaring global R&D costs of the global pharmaceutical industry, multinational pharmaceutical giants are also keen to extend the reach of cooperation to China, a medical power with research and cost advantages. Under the current national policy of promoting biopharmaceuticals as a key development industry, the domestic biopharmaceutical sector is even more business opportunities.

This time, the global biopharmaceutical giant Samsung Bioepis and the domestic biopharmaceutical leader Sansheng Pharmaceutical, the two of them will collide in the field of medical innovation?

First, when "Gao Fu Shuai" meets "White Fumei",

Samsung Bioepis is an international biopharmaceutical giant founded in 2012. It develops biosimilars in research pipelines covering immunology, oncology, ophthalmology and hematology. Although the company was not established for a long time, it can be described as a "rich and handsome" in the field of bio-pharmaceuticals.

As a joint venture between technology giant Samsung and biopharmaceutical giant Biogen, in just six years, Samsung Bioepis has not only established a new business from 0 to 1 in the generics field, but also has seven similar organisms. Pharmaceutical products have become the largest biopharmaceutical pipeline among Korean pharmaceutical companies.

The company currently has four approved and marketed biosimilar products in Europe, including etanercept, infliximab, adalimumab, and trastuzumab. In addition, in the United States, Samsung Bioepis has an approved and marketed biosimilar drug, infliximab, and SB5 (adalimumab) and SB3 (trastuzumab) biosimilar drugs are under research. In the process of approval.

From the above, you can see the strength of Samsung Bioepis is not bad. In fact, as a company that develops biosimilar drugs, it also cooperates with mature pharmaceutical companies such as Biogen and Merck & Co in the marketing, so it not only has the global market leading biological product development and production strength, but also has a wealth of Inside and outside the industryAdvantages of resources.

Next, the domestic pharmaceutical company Sansheng Pharmaceutical, which is the marriage of this marriage, is also considered to be a veritable "Bai Fumei".

As a leading company in the domestic biopharmaceutical industry, Sansheng Pharmaceutical has a market-leading biopharmaceutical product line in biopharmaceuticals such as cancer, autoimmune diseases and kidney diseases. Its main products include Tebiao, Yisaipu, Yibiao, etc. Maintaining a leading position in the domestic market.

According to IMS data, in the first half of 2018, Tebiao's market share in the treatment of thrombocytopenia was 64.4%. Yisaipu has a market share of 64.9% in tumor necrosis factor inhibitor products.

In addition to its strong flagship product, the company is committed to building an innovative product pipeline that currently has 32 research products, 19 of which are monoclonal antibodies or biopharmaceuticals.

As we all know, production capacity is also an important indicator for biopharmaceutical companies. Sansheng Pharmaceutical's production capacity covers recombinant proteins, monoclonal antibodies and chemically synthesized molecules. The 2018 mid-year report shows that Sansheng Pharmaceutical has a cloned antibody production facility with an annual output of 38,000 liters and has more than 25 years of production experience.

Therefore, one is the leading international biopharmaceutical giant in the global market, with research and development strength and rich resources. The other is the domestic biopharmaceutical "head snake", which has extremely rich experience in local operations. Under the blessing of the two, it can be said that it is a strong alliance, and both parties are expected to create extraordinary achievements in the domestic biopharmaceutical market.

Second, the pharmaceutical giants marry, why is the crystallization of love shining?

From the specific details of the cooperation, Samsung Bioepis cooperated with Sansheng Pharmaceutical to combine the mature development platform of Samsung Bioepis with the powerful commercial platform of Sansheng Pharmaceutical to rapidly expand the biosimilar drug business to the Chinese market.

This cooperation model is not without precedent for Samsung Boepis. As mentioned earlier, the company's cooperation with Baijian and Merck (known as Merck in the United States and Canada) is similar in Europe and the United States.

According to the specific cooperation details, according to the agreement, Samsung Bioepis will be responsible for the production and supply of products, and carry out a series of cooperation with Sansheng Pharmaceutical, including clinical development, registration and commercialization in China. Samsung Bioepis will also receive advance payment and product supply revenue from Sansheng Pharmaceutical and will be eligible for relevant clinical and regulatory milestone payments.

Next, let's take a look at the bio-similar drug research product SB8 of bevacizumab in this collaboration, and explore the deep logic and opportunities behind the deep cooperation between the two.

Bevacizumab is a recombinant humanized monoclonal antibody, the world's first anti-tumor angiogenesis drug. It has been used for colorectal cancer since the first time it was approved for marketing in the United States in 2004. The efficacy and safety of first-line treatment of various tumors such as lung cancer, breast cancer, malignant glioma, renal cell carcinoma and ovarian cancer have been confirmed by many clinical trials. At present, Avastin has been approved in more than 120 countries and regions in the United States, Europe and other countries. To date, more than one million patients worldwide have received treatment for this drug.

In 2017, Bevacizumab achieved a global sales income of 6.808 billion Swiss francs, ranking third in the global cancer drug sales list.

Looking at the domestic situation, as early as 2010, bevacizumab was approved for metastatic colorectal cancer (mCRC) in China, and by 2016, the drug was approved for non-small cell (type) lung cancer. (NSCLC). In 2017, bevacizumab was also successfully incorporated into the National Health Insurance Directory.

It is worth mentioning that the European patent protection of bevacizumab has expired in 2018, and the US patent protection will expire in 2019, so the drug has also become a popular imitation object. However, even if there is no bevacizumab biosimilar drug approved for sale in China, only Qilu Pharmaceutical is in the process of submitting the listing application. From this point of view, the reason for the selection of bevacizumab in the field of cooperation between the two sides is undoubtedly to see the huge market demand and potential business opportunities of bevacizumab.

At present, the incidence and mortality of malignant tumors in China are very high, and the indications for bevacizumab in China are mainly metastatic colorectal cancer and non-small cell lung cancer, which have broad market prospects in China.

According to the National Cancer Center data, in 2015, there were 376,000 new cases of colorectal cancer in China, and 191,000 deaths (incidence rate 26.6 per 100,000 people, mortality rate 13.5 per 100,000 people); the incidence of colon cancer increased significantly. In addition, due to the lack of specificity of clinical symptoms of colorectal cancer, there is no obvious abnormal change in the early stage of the patient, so about 70% of patients with colorectal cancer are in the advanced stage. For these patients, most also require medication or chemotherapy.

In addition, we look at lung cancer, which is the cancer with the highest morbidity and mortality in China. In 2015, there were 733,000 new cases and 61,000 deaths. (The incidence rate is 51.9 per 100,000 people, the mortality rate is 43.2 per 100,000 people), of which more than 90% of lung cancer cases are non-small cell lung cancer.

From the above, it is not difficult to see that the huge market prospects have extended the reach of both sides to the field of bevacizumab. Focusing on Samsung Bioepis's biosimilar drug biosimilar drug research product SB8, the two biopharmaceutical giants have cooperated strongly, which will accelerate the clinical research and development of SB8 in China, and will be able to seize the opportunity and win a bigger Market opportunities.

Third, behind the marriage, the star-like sea of ​​biological similar drugs

This time, the two major biopharmaceutical giants will not only help accelerate the development and commercialization of biosimilar drugs for bevacizumab in the world, but in fact, the whole organism is similar. The star of the medicine.

In recent years, with the arrival of patent cliffs, numerousbiomedicineThe company's best-selling drugs have lost patent protection. The biosimilar drug market has become a hot spot in the pharmaceutical industry. Major pharmaceutical companies have chased this big cake and have driven the development of biosimilar drugs in the domestic and international pharmaceutical markets. The background of Samsung Bioepis was also the business opportunity that Samsung, a technology giant, saw in the early stages.

Since many heavy biopharmaceutical patents expired in 2015-2020, biosimilar drugs are expected to be widely approved in 2018-2022. According to Macquarie Research, biosimilars will be the fastest-growing phase of biosimilars from 2016 to 2020. It is estimated to grow at a compound annual growth rate of 40%. It is estimated that global biosimilars will reach US$30.4 billion by 2020. Market size. Under the patented Damocles sword, biosimilar drugs are already on the eve of the outbreak.

The biggest benefit of the listing of biosimilar drugs is to lower the price of the drug to better meet the public's demand for biotherapeutic products. Focusing on the domestic market, as a big country with a population of 1.4 billion, its drug demand is obviously self-evident. Under the advantage of the price reduction of biosimilar drugs, this ageing population will increase and the gap between rich and poor will undoubtedly be here. A field has a huge opportunity.

The marriage of the two giants, with their respective advantages, is bound to show more attractive performance in this blue ocean.

Fourth, summary

Along with the expiration of a number of heavy biopharmaceutical patents, a large number of biosimilar drugs will enter the market in the future. The domestic policy guidance through "4+7 quantity procurement" is also constantly diverting space for therapeutic innovation drugs that are just needed in clinical practice. In the long run, it will also be very beneficial to open up the market space for innovative drugs and high-end generic drugs represented by biosimilar drugs. At present, the mainstream view is that "4+7 quantity procurement" is intended to reduce the medical insurance reimbursement expenses of chemical generic drugs, and the saved medical insurance funds will be used for the reimbursement of biopharmaceuticals and innovative drugs. In 2018, the entry of O medicine and K medicine into the medical insurance catalogue is the beginning of this small trend. In the future, more biopharmaceuticals and innovative drugs will enter the medical insurance, and biopharmaceuticals and innovative drugs will become a new blue ocean.

However, in such a blue ocean, it is easy to win, and it is bound to have a strong comprehensive strength. As the two giants of biopharmaceuticals, Samsung Bioepis and Sansheng Pharmaceutical, on the one hand, strong capital will strongly support its expansion on the road of innovation. Earth, on the other hand, competitive products and strong commercialization capabilities will also help it quickly attack the market and seize market opportunities. The two major pharmaceutical companies, each with their own advantages and cooperation, are bound to form a stronger market competitiveness and are expected to stand out in the industry.

Looking into the future, in the context of the current major pharmaceutical companies in the field of immunotherapy (PD1 antibody) killing and raging, this also means that the blue ocean of biosimilar drugs will soon become the Red Sea, and the fate of the price war will be very Coming soon. The international marriage of Samsung Bioepis and Sansheng Pharmaceutical will, to a certain extent, indicate that the two companies have already taken the lead in product quality and reached international standards. The strong comprehensive strength will also strongly support the expansion of the company's future product capacity, and is expected to win a comprehensive victory on the biosimilar drug track through a series of advantages such as cost, capital and channels.