Well-known pharmaceutical companies $5 billion of heavy-weight products, Phase III clinical failure again

PFIZER (Chinese: AiboXin) has failed in peneLOPE-B, the second major Phase 3 clinical study for the treatment of HR-/HER2-Early Breast Cancer, Pfizer announced recently.
this is another failure in the clinical study of early breast cancer in May this year after the failure of the combined endocrine therapy for the treatment of HR-/HER2-PHASE III.
It is understood that Ibrance is a start-up oral targeted CDK4/6 inhibitor that selectively inhibits cell cycle protein-dependent kinases 4 and 6 (CDK4/6), restores cell cycle control, and blocks tumor cell proliferation.
was first approved for listing in February 2015 and has been approved by more than 90 countries worldwide for first- and second-line treatments for HR-/HER2-breast cancer.
in China, Ibrance was approved in August 2018 as a combination of aromatase inhibitors as an initial endocrine therapy for the treatment of post-menocentrogenic women with HR-/HER2-localized advanced or metastatic breast cancer.
2019, Ibrance's global sales reached $4,961 million, up 23% from the previous year.
, Ibrance already has nearly 90% of the market share in the CDK inhibitor category and 80% of the first-tier CDK inhibitor market.
But the industry believes that while Pfizer's Ibrace is close to $5 billion in global sales in 2019, the back-to-back missed opportunities in the early stages of breast cancer research and development will undoubtedly slow its growth.
, two clinical failures in six months will no doubt cast a shadow over Ibrace's smooth entry into the health-care catalog.
In addition, it is worth noting that anti-tumor drugs as a major direction of global drug research and development, and CDK4/6 inhibitor research and development heat as the second most popular varieties after PD-(L)1, is attracting many pharmaceutical companies to increase research and development efforts.
that up to now, Novaral, Lilly CDK4/6 inhibitors have been approved for the market, but also in large-scale clinical Phase III trials.
industry expects a future market war for CDK4/6 inhibitors to be a one-way battle.
In fact, innovative drugs represent a country's technical level and ability in the field of medicine, but it should be noted that the research and development of new drugs has been difficult, there is a very high technical threshold, from compound screening to market success rate of only 3, each innovative drug research and development needs at least 10 years, and the upfront investment costs are high, in the United States, for example, the average single innovative drug needs to invest 600 million to 1 billion U.S. dollars, and China's innovation drug research and development average of several billion yuan.
Therefore, for domestic pharmaceutical companies, although in recent years, with the frequent introduction of policy measures, resource allocation and investment environment has been greatly improved, China's pharmaceutical industry innovation trend began to emerge, but still can not easily carry out a new drug research and development.
In the future, how to develop new drugs with real clinical and market value, stand out from homogenized research and development, and accelerate the listing in China and the world will still be a long-term topic that domestic pharmaceutical companies and new drug development institutions face together and take time to study.