New 1 billion varieties of Kelun pharmaceutical will be born! Is it courage or strength to challenge Roche?

Recently, Kelun pharmaceutical announced that the antibody coupling drug "a166 for injection" developed by the subsidiary Sichuan Kelun Botai Biological Technology Co., Ltd was approved by CFDA after the FDA allowed the clinical trials The product is registered as a class 1 therapeutic biological product It is reported that a166 for injection is the first third generation of anti her2adc with innovative linker and high active toxin small molecule, which is used in the treatment of HER2 positive breast cancer, gastric cancer and other malignant tumors in the world   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; font-size: 17px; letter-spacing: 0.544px; widows: 1; font-family: -apple-system-font, Bl inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; line-height: 25.6px; color: rgb(62, 62, 62); border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> to challenge Roche's new anticancer drugs, anti drug Co njugate (ADC) is a highly cytotoxic chemotherapeutic drug, which is formed by coupling small molecule drugs with monoclonal antibodies It has strong killing power of small molecule drugs and high targeting of pure monoclonal antibodies In recent years, it has become a research and development hotspot of tumor targeted treatment It is reported that at present, ADC drugs targeting HER2 in the world include kadcyla (ADO trastuzumab emtansine, also known as ADO trastuzumab or t-dm1) of Roche company It is a drug coupled with trastuzumab and DM1 cytotoxic agent (a derivative of metoprolol, microtubule inhibitor) It has HER2 inhibition of trastuzumab and cytotoxicity of DM1 The product was approved by FDA in 2013 and used for the treatment of HER2 positive metastatic breast cancer patients It has not been listed in China yet Figure 1: global sales of Roche's kadcyla from 2015 to 2017 (unit: CHF 100 million) (data source: performance database of MNE) According to the performance database of MNE, the global sales of Roche's kadcyla in 2015-2017 showed a rapid upward trend, rising to CHF 914 million (about USD 915 million) in 2017 The growth rate in the past two years has remained at about 8% - 10% If this growth rate can be maintained, the sales volume in 2018 may exceed US $1 billion It is reported that Sichuan Kelun Botai biology, a subsidiary of Kelun pharmaceutical, submitted the clinical trial application of a166 for injection to CFDA in August 2017 and was accepted Up to now, the company has invested about 32 million yuan in research and development of a166 for injection   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; font-size: 17px; letter-spacing: 0.544px; widows: 1; font-family: -apple-system-font, Bl inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; line-height: 25.6px; color: rgb(62, 62, 62); border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> six HER2 targeted drugs in the world, three of which have entered the domestic market Table 1: current global sales of HER2 targeted drugs for breast cancer treatment (data source: M-net database) At present, six HER2 targeted drugs for the treatment of metastatic or advanced breast cancer have been approved by FDA, among which trastuzumab and lapatinib have been listed in China, and afatinib has also been approved by CFDA to enter the Chinese market in 2017 Figure 2: Sales of trastuzumab (unit: 10000 yuan) (source: China's public medical institutions terminal competition pattern) in public medical institutions in 2013-2016 (trade name: Herceptin) As the earliest target drug of HER2, it was approved by FDA in 1998 It is mainly suitable for metastatic breast cancer, metastatic gastric cancer and gastric esophageal junction adenocarcinoma with overexpression of HER2 Trastuzumab was listed in Europe in 2000 and Japan in 2001 CFDA approved trastuzumab to be listed in China in 2002 The main market of trastuzumab sold in China is in China's public medical institutions (including China's urban public hospitals, county-level public hospitals, urban community centers and township health centers) From 2013 to 2016, the sales of trastuzumab remained above 1 billion yuan, with a continuous upward trend, rising to 1913 million yuan in 2016 In 2016, the sales volume of trastuzumab in China's urban retail drugstore terminals was also close to 361 million yuan Figure 3: Sales of lapatinib (unit: 10000 yuan) (source: the competition pattern of China's public medical institutions' terminals on the Internet) in China's public medical institutions from 2014 to 2016 It is an oral small molecule epidermal growth factor kinase inhibitor developed by GlaxoSmithKline It can be used with capecitabine in combination with anthracycline drugs, paclitaxel and trastuzumab in the past treatment of HER2 overexpression in patients with advanced or metastatic breast cancer The product was approved by FDA in 2007, listed in Europe in 2008, and listed in China by CFDA in 2013 Lapatinib is a small molecule oral preparation, and its sales volume is relatively small compared with trastuzumab, which is the same in China According to the data of minenet, the main market of lapatini's sales in China is the terminal of public medical institutions in China After its listing, the sales volume has been soaring year by year, and the sales volume in 2016 has increased to 27.33 million yuan Afatinib is another small molecule HER2 targeting drug, which is suitable for the first-line treatment of advanced non-small cell lung cancer (NSCLC) and the patients with HER2 positive advanced breast cancer The product was approved by FDA in 2013 In February 2017, afatini (Chinese trade name: jitari) obtained CFDA's import drug registration certificate and entered the domestic market after July What is the sales situation of the product after its launch? We are waiting for the data update in 2017   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; font-size: 17px; letter-spacing: 0.544px; widows: 1; font-family: -apple-system-font, Bl inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; line-height: 25.6px; color: rgb(62, 62, 62); border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> 7 global hot new products under development enter the clinical market, with a market scale of 10 billion US dollars in 2023 Table 2: current research status of hot HER2 targeted new drugs for breast cancer treatment (data source: global drug research and development library of minenet) Globally, breast cancer is the most common malignant tumor in the female population About 20% to 30% of all cases are HER2 positive breast cancer Compared with other types of breast cancer, HER2 positive breast cancer has faster disease progression, higher malignancy, easier recurrence and metastasis, and worse prognosis Some experts believe that in recent years, factors such as the rapid market acceptance of high biological agents and the aggravation of population aging are important driving forces for the rapid growth of the global HER2 positive breast cancer market According to the report released by global data, a well-known global market research company, the HER2 positive breast cancer market will grow at a compound annual growth rate of 9.82% in the next 10 years, and is expected to reach 12.63 billion US dollars in 2023 According to the latest cancer status and trend in China in 2017 released by the National Cancer Center, lung cancer ranks first in the death rate of male patients in China, while breast cancer ranks first in female patients The incidence rate of breast cancer in China is lower than that in western countries, but the growth rate is the highest in the world At present, the new anticancer drug a166 for injection of Kelun Pharmaceutical Co., Ltd is still some time from its official launch, but as a domestic new drug, it undoubtedly gives the market and patients more expectations Source: public announcement of listed companies, minenet database