The approval of new drugs is the holy grail for large and small pharmaceutical companies, and the track record of bringing new drugs to the market is one of the ultimate tests of R&D strength, but not every new drug on the market will turn into the best performance and bring companies Outstanding contribution to performance. Recently, Evaluate Vantage released a report showing that in the past five years, the world's 11 largest drugmakers have introduced 76 new drugs to the market. Novartis was approved to market with 12 new drugs, ranking first, including gene therapy Zolgensma and the first approved CAR-T cell therapy Kymriah. Bristol-Myers Squibb ranked last with three drugs, and the report showed that three new drugs were also attributed to its $74 billion Celgene acquisition. In addition, Merck and Roche tied for second place, with 9 each approved for listing, while Eli Lilly owns 8 and Pfizer and GlaxoSmithKline each have 7. Sanofi has received 6 approvals in the past five years, while AbbVie, Johnson & Johnson and AstraZeneca have also received 5 approvals each.
Note: Evaluate's analysis only covers projects owned by the company at the time of approval. Evaluate said that the report did not weigh the impact of drugs purchased after approval, even though it was "a legal way to establish a pharmaceutical company."
New drugs approved to boost performance, Roche, Eli Lilly, AbbVie, etc. are particularly good
It is particularly worth noting that although Roche, Eli Lilly, AbbVie, etc. have not approved as many new drugs as Novartis in 5 years, their sales have received the greatest performance boost from the sales of approved new drugs. Newly listed drugs It accounts for one third or more of the net present value (NPV) of each company's listed products and new drugs. According to the Evaluate report, Roche’s NPV totaled approximately US$217.22 billion, of which nearly 65% came from approved new drugs, mainly due to the rapid growth in sales of Roche’s new drugs Tecentriq, Hemlibra, Ocrevus, Perjeta and Kadcyla. In particular, Roche Pharmaceuticals Tecentriq (atezolizumab, atezolizumab), according to Roche Pharmaceuticals financial report, in 2020 Tecentriq sales reached 2.7 billion Swiss francs (approximately 2.94 billion US dollars), a year-on-year increase of 55%. It is a drug with the fastest growth in sales of several new drugs, and it has made outstanding contributions to offset the competition brought by biosimilar drugs.
Image source: Yaozhi Data Global best-selling drug sales database
Tecentriq is a monoclonal antibody that targets the PD-L1 protein. Atelizumab binds to PD-L1 expressed on tumor cells and tumor infiltrating immune cells, blocking its interaction with PD-1 and B7.1 receptors. By inhibiting PD-L1, T cells can be activated to destroy tumor cells. It has the potential as a basic compatible therapy for cancer immunotherapy, targeted drugs and various cancer chemotherapy regimens. As early as May 2016, atelizumab was first approved by the U.S. FDA for the second-line treatment of bladder cancer; in October of the same year, the FDA approved for the treatment of metastatic NSCLC; in December 2018, atelizumab was combined with Bevacizumab, paclitaxel, and carboplatin were again approved for use in patients with metastatic non-squamous NSCLC without EGFR or ALK gene mutations; in March 2019, the only tumor immunotherapy for TNBC was approved for marketing. In the first-line treatment of SCLC and triple-negative breast cancer; in May 2020, the European Commission (EC) approved Tecentriq as a first-line (initial) monotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC). The fourth indication obtained in the field of non-small cell lung cancer. At present, Tecentriq has been approved for marketing in China, combined with chemotherapy for the first-line treatment of extensive-stage small cell lung cancer. Eli Lilly also has about 52% of NPV driven by new products, valued at 105.24 billion U.S. dollars; including Trulicity (dulaglycotide), Taltz (ecchizumab), bamlanivimab monoclonal antibody, Verzenio (abesil), Olumiant ( Baritinib) and other star drugs.According to Eli Lilly's 2020 financial report, Verzenio has the fastest growth rate. In 2019, its sales were 580 millio
Image source: Yaozhi Data Global best-selling drug sales database
Verzenio is a CDK4/6 inhibitor, the third CDK4/6 inhibitor approved by the United States in September 2017, for the single-agent treatment of ER+/HER2- advanced or metastatic breast cancer that has undergone endocrine therapy and chemotherapy. , Or combined with fulvestrant as a second-line treatment for HR+, Her2-advanced or metastatic breast cancer that has undergone endocrine therapy. On February 26, 2018, the FDA approved the third indication of Verzenio, which is combined with aromatase inhibitors as the initial endocrine therapy for advanced or metastatic breast cancer in postmenopausal women with HR+ and Her2-. It is worth noting that Verzenio is the only CDK4/6 inhibitor approved as a stand-alone therapy, and it has been considered one of the key factors driving the growth of Eli Lilly's performance. In addition, in June 2020, Eli Lilly announced that Verzenio combined with ET in the treatment of high-risk HR+/HER2-early breast cancer phase 3 clinical monarchE, compared with ET therapy, significantly reduces the risk of recurrence or death; becoming the only one that can significantly improve HR+/HER2- early breast cancer The success of the CDK4/6 inhibitors, again, may greatly disturb the market structure of the entire CDK4/6 inhibitors, and further drive business growth.In addition, according to Evaluate analysis, about 36% of AbbVie's US$209.48 billion net present value is also attributable to the launch of its new drug. Its pillar product Humira contributed US$19.832 billion, accounting for AbbVie’s entire company’s revenue. 43%. In addition, GlaxoSmithKline’s “performance in this analysis is not too bad”. About one-third of its US$128.56 billion net present value comes from new drugs. Its NPV statistics include two new HIV drugs split by GSK and ViiV Healthcare, including cabotegravir.
Expand the indications of pillar products and consolidate the product "king" status
A new drug has been developed for the first time and successfully launched into the market, which certainly demonstrates the company's R&D strength; but this is only part of the company's R&D strategy, and it is also very important to expand the use of existing drugs, especially in cancer and immunology. For example, atelizumab (Tecentriq), which has made a significant contribution to the growth of Roche Pharmaceuticals’ performance; Roche has formulated a wide range of development plans for it, including a number of ongoing and planned phase III studies, involving various types of Lung cancer, genitourinary system cancer, skin cancer, breast cancer, gastrointestinal cancer, gynecological cancer and head and neck cancer. Including studies of Tecentriq alone or in combination with other drugs. It is believed that with the expansion of more indications for Tecentriq, the market performance of atelizumab will become more eye-catching. In addition, Bristol-Myers Squibb, which ranked the bottom of the list of new drugs approved within 5 years, has stepped up research on Opdivo's expanded indications. Opdivo is a monoclonal antibody that targets PD-1. By inhibiting the signal pathway mediated by PD-1 immune checkpoint protein, it enhances the anti-cancer immune response of T lymphocytes, thereby inhibiting the growth of tumor cells. According to public data, after Opdivo was first approved by the FDA in 2014, so far, it has been approved for more than ten cancer indications worldwide, and has been approved for cancer treatment in more than 60 countries, involving lung cancer ( Non-small cell lung cancer and small cell lung cancer), melanoma, kidney cancer, Hodgkin’s lymphoma, head and neck squamous cell carcinoma, bladder cancer, colorectal cancer, liver cancer, gastric cancer, etc., have also been approved in China Multiple indications. It is reported that BMS has carried out a total of more than 60 clinical studies on Opdivo and Yervoy single-drug or multiple combination programs. In addition, it is worth mentioning that in China, under the support of medical policy reform, centralized drug procurement, and medical insurance negotiations, popular targets have been promoted, especially the serious homogeneity of PD-1/PD-L1, and the single The indications of the company no longer have a competitive advantage, and major research and development companies are constantly expanding and expanding their use paths. In the future, it may be that the more indications, the better the world.
references:
1. Novartis may have the most new drug approvals, but Roche, Lilly and AbbVie's launches win on value: report
2. Novartis leads and Bristol lags on novel drug approvals
3. Public information such as corporate financial reports
