Pharmaceutical companies are accelerating the development of new indications, and competition in this area is fierce

【Pharmaceutical Network Industry News】Recently, Merck announced that its PD-1 inhibitor pembrolizumab (trade name: KEYTRUDA ®️) has been approved by the National Medical Products Administration (NMPA) of China in combination with chemotherapy neoadjuvant therapy and continues to pembrolizumab monotherapy after surgery for the treatment
of patients with early-stage high-risk triple-negative breast cancer (TNBC) with a well-validated test to evaluate tumors expressing PD-L1 (composite positive score (CPS) ≥20).
。 Pharmaceutical companies are accelerating the development of new indications, and the field is highly competitive! (Image source: Pharmaceutical Network) It is understood that this is the 10th indication approved for pembrolizumab in China, after it has been approved for second-line treatment of advanced melanoma, first-line treatment of advanced squamous NSCLC in combination chemotherapy, second-line treatment of esophageal cancer, first-line treatment of advanced head and neck squamous cell carcinoma with CPS≥20 and many other indications
.
The industry believes that the approval of the new indication of pembrolizumab in China will open a new journey of tumor immunotherapy in the field of breast cancer, and is expected to bring new choices and hopes
to more patients and families.
Thanks to the reform of China's drug review and approval system and the continuous support of innovative drugs by China's drug regulatory authorities, a large number of imported new drugs have actually accelerated the expansion of new indications
in recent years.
On September 22, according to media reports, Eli Lilly's oral lung cancer drug Retevmo has also been approved by the FDA to accelerate the expansion of indications for the treatment of locally advanced or metastatic solid tumors with RET gene fusion
.
At present, many domestic new drugs are also accelerating their layout
in this regard.
For example, in April, the State Food and Drug Administration approved the domestic self-developed class 1 new drug anlotinib for patients with locally advanced or metastatic differentiated thyroid cancer (RAIR-DTC) resistant to inoperable iodine therapy
.
This is the fifth indication approved for anlotinib in 4 years, and previously approved indications have included advanced non-small cell lung cancer, soft tissue sarcoma, small cell lung cancer, medullary thyroid cancer, etc
.
Hengrui Pharmaceutical's application for a number of new drugs and new indications in the third quarter has also been accepted, including the innovative drug SHR8554 injection for the treatment of moderate to severe pain after abdominal surgery
.
It is worth mentioning that at present, Hengrui has launched 11 innovative drugs, more than 60 innovative drugs are under clinical development, and more than 260 clinical trials have been carried out
at home and abroad 。 In addition, Innovent Biologics' Daboshu (Cindilimab Injection) has been declared for marketing for seven indications at the end of December last year, including Daboshu ® ® in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of unsystematically treated epidermal growth factor receptor (EGFR) gene mutation-negative and anaplastic lymphoma kinase (ALK)-negative advanced or recurrent non-squamous non-small cell lung cancer ("NSQ NSCLC"); In combination with gemcitabine and platinum-based chemotherapy for first-line treatment of unresectable advanced or recurrent squamous non-small cell lung cancer.
.
.
Among the many drugs, the PD-1 field is undoubtedly the area
where the indications are in fierce demand.
It is reported
.
At present, PD-1 in China involves 12 types of cancer, and a total of 50 suitable diseases
have been approved.
Including Hengrui Pharmaceutical's carrelizumab 8 items, Merck Palbolizumab 8 items, BeiGene's tislelizumab 7 items, etc.

Industry analysts believe that exploring the possibility of new indications of innovative drugs is a very important work
for pharmaceutical companies to carry out clinical trials.
Because the development of new indications can not only help companies form new patent results, but also allow innovative drugs to benefit more patients
.
At present, large pharmaceutical companies at home and abroad attach great importance to the development of new indications of innovative drugs, and are continuously expanding the field of
drug use.
As major companies actively explore the indications of innovative drugs, it is expected to help more patients enjoy the treatment of innovative drugs and effectively reduce the burden
of patients.
However, the crisis and the opportunity are together, and more indications may lead to the phenomenon of product homogenization becoming more prominent, and make enterprises can only seize the market
through price wars.
Therefore, how to solve the "crash" in indications in the future, expand the field of drug use, and develop more high-barrier directions will become a problem
that pharmaceutical companies need to think about.
Disclaimer: Under no circumstances does the information or opinions expressed herein constitute investment advice
to anyone.