一. Overview
The ASCO annual meeting is known as the "Oscar Ceremony" of international oncology, and the research that is selected for the Oral Abstract Session every year is particularly concerned by the industry. The 2021 ASCO annual meeting will be held from June 4th to 8th. Recently, the ASCO official website announced the research abstracts selected for the 2021 ASCO annual meeting. According to statistics, a total of about 20 Chinese scholars were selected for oral reports at this annual meeting, the highest in history, and hundreds of domestically produced innovations competed to go abroad.
Table 1 Summary of the summary of domestic new drugs 2021 ASC0
Source: Announcements and public information of various companies
二. The domestically-made innovative collectives went overseas, and Hengrui performed brilliantly
According to the published summary information, we can see that domestic monoclonal antibodies, double antibodies, ADCs, and small molecule drugs have some dazzling results. In the field of antibody drugs, PD-1/L1 drugs are still the focus and the competition is fierce. Hengrui Pharmaceuticals, Kangning Jereh, Kangfang Bio... many Chinese companies are deploying the target drugs. However, it is not necessarily a bad thing to have a large number of companies. Full competition can lead to better drugs. Although PD-1/L1 is severely involuted, this time we saw that the domestic PD-1 monoclonal antibody has begun to advance to more front-line treatments such as adjuvant/neoadjuvant. In the field of small molecules, EGFR inhibitors have always been the focus of attention. As the first domestic third-generation EGFR-TKI, Ametinib has been approved for second-line use in NSCLC patients in China. The ASCO 2021 meeting will disclose the detailed first-line PK data of Ametinib vs. Gefitinib for the first time. Studies have shown that compared with existing first-line standard treatment drugs, the use of amitinib can significantly prolong PFS (mPFS is 19.3 months vs. 9.9 months), and DoR is also significantly prolonged (mDoR is 18.1 months vs. 8.3 months) month). According to the big data monitoring system of Yaozhi Public Opinion, the keywords related to Hengrui Medicine include leading, medicine, drugs, etc. The keyword cloud is as shown in the figure below.
Keyword Cloud
Although some people doubt that Hengrui's expansion is not as good as some rookies, Hengrui's comprehensive strength is hard to beat by other domestic companies, and it is recognized as a leading pharmaceutical company. On Fast follow, Hengrui has a rapid layout, involving tumors, autoimmune diseases and other fields, and the pipeline is in the forefront of the domestic echelon. It is reported that in this year's ASCO, Hengrui Medicine has 5 Oral studies, 22 Posters and 12 Abstracts appearing on ASCO, involving apatinib, pyrrotinib, carrelizumab, SHR1701 (PD-L1/TGFβ), SR6390 (CDK4/6), SHR7390 (MEK1/2), Famitinib, covering lung cancer, liver cancer, gastric cancer, esophageal cancer, breast cancer and many other types of cancer. A total of 16 studies from Chinese scholars were selected into the Oral Abstract Session this year, and Hengrui accounted for 5 of them.
1. A randomized, double-blind, placebo-controlled phase III clinical study (ESCORT-1st) of carrelizumab combined with chemotherapy versus chemotherapy for untreated patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC). From December 3, 2018 to May 12, 2020, 596 patients received randomization. Of these, 298 received carrelizumab + chemotherapy, and 297 received placebo + chemotherapy. With a median follow-up of 10.8 months, carrelizumab combined with chemotherapy significantly improved OS compared with placebo + chemotherapy (median, 15.3 months [95% CI 12.8-17.3] vs 12.0 months [11.0-13.3] .
2. A randomized controlled, double-blind, multi-center phase III clinical trial (CAPTAIN-1st) of carrelizumab combined with gemcitabine and cisplatin in the first-line treatment of recurrent/metastatic nasopharyngeal carcinoma. The median PFS in the carrelizumab group was 10.8 months (95% CI 8.5-13.6) and in the placebo group was 6.9 months (95% CI 5.9-7.9) (HR0.51 [95% CI 0.37-0.69 ]; unilateral detection p<0.0001).
3. Dapicillil versus placebo plus fulvestrant in the treatment of HR+/HER2-advanced breast cancer (DAWNA-1) that has relapsed or progressed from previous endocrine therapy: a multicenter, randomized, phase 3 study. Dapicillide + Fulvestrant significantly improved the PFS assessed by INV (median 15.7 [95% CI 11.1-NR] vs 7.2 [95% CI 5.6-9.2] months; HR, 0.42 [95% CI 0.31-0.58 ];P<0.0001).
4. Famitinib combined with carrelizumab + albumin paclitaxel in the first-line treatment of immunomodulatory advanced triple-negative breast cancer phase II study. The median response time was 1.8 months (95% CI 1.8-2.0 months). At a median follow-up of 9.0 months, PFS and DoR have not yet been achieved.
5. Phase I study of HR-1701 (a PD-L1&TGF-β double antibody) in the treatment of patients with advanced solid tumors. Of 49 patients, 45 patients completed at least one efficacy evaluation. ORR was 17.8% (95% CI, 8.0%-32.1%), and 8 patients achieved PR. The DCR is 40.0%. Most PR patients are still responding (7/8), and the median DoR has not yet been reached.
In addition to the five Oral, pyrrotinib has published several phase II results for gastrointestinal tumors, non-small cell lung cancer, and breast cancer, and two phase II clinical results for breast cancer have made excellent results. The combined use data of multiple cancer types of the Shuangai combination (carrelizumab + apatinib) disclosed that the OS data of advanced liver cancer was more than 20 months, and the two-year OS rate exceeded 40%. In addition, SHR7390 (MEK1/2) also has data for single-drug and combined use. Hengrui Medicine has been in overseas markets for many years, and several generic drugs have been approved for listing in multiple markets. In terms of the internationalization of innovative drugs, Hengrui currently has nearly 20 projects approved to carry out global multi-center or regional clinical research. Among them, karelizumab combined with apatinib, fluzoparib and other products have been used internationally. The center carries out Phase III clinical trials.
三. summary and thinking
In recent years, my country's pharmaceutical market has developed rapidly, and it is now the world's second largest pharmaceutical market. my country’s bulk and specialty APIs are already the largest export country; many companies in my country have realized the export of preparations, and outstanding companies have also passed the preparations certification of Europe and the United States to achieve standardized market export; and the domestic innovative drugs have been accumulated for many years. Entering the harvest period. But we must also see that the competitive environment is very fierce, the track is very crowded, and some popular targets are being made by many people. Moreover, domestic innovation is still dominated by fast follow, and there are still considerable difficulties in the first innovative drugs. The road to innovation is long and difficult. We will wait and see whether domestic innovative pharmaceutical companies represented by Hengrui can go overseas smoothly and grow into MNC.
