Innovative drugs are facing a new round of "big tests", and a number of domestic innovative drugs are rushing to enter

【Pharmaceutical Network Industry News】In the pharmaceutical industry, one of the highlights at the end of the year is the upcoming new round of national medical insurance negotiations, according to the forecast of the 2021 national talks (November 9-11, 2021), this year's national talks may be launched
this month.
Among the 343 drugs that passed the formal review this round, more than 20 domestic blockbuster innovative drugs (including the introduction) participated in the negotiations for the
first time.
Innovative drugs are facing a new round of "big test", and the industry believes that it is a good opportunity for domestic innovative drugs, especially those that have just been approved, and if they successfully enter medical insurance, they will accelerate their volume
.
And this year's medical insurance negotiations may reduce the price of innovative drugs more
moderately.
According to Essence Securities Research Report, according to the current simple renewal rules, the price reduction rate of innovative drugs after new indications will be between 0% and 44%, which is narrowed compared with the possible average reduction of 50%-60% in renegotiation
.
Judging from the recent progress of domestic innovative drugs, many domestic innovative drugs are seizing the time to enter the market, and the progress of products approved for marketing and clinical approval continues
.
For example, in the cycle from November 4 to November 10, the Class 1 innovative drug Linplisset tablets declared by Yingli Pharmaceutical were approved for marketing for the treatment
of relapsed/refractory (R/R) follicular lymphoma (FL).
New data from the company's phase II clinical trial in China for the treatment of R/R FL patients in the treatment of R/R FL released by the company in 2022 shows that patients only need to take the drug orally once a day, which has good efficacy, safety and medication compliance
.
After the approval for marketing, Yingli Pharmaceutical will cooperate with Hengrui, which has extensive commercial operation experience and clinical development capabilities, to jointly promote the commercialization
of Intari in China.
Previously, Linplisset has received breakthrough therapy designation from NMPA for the treatment of R/R FL and three orphan drug designations issued by the US FDA for FL, chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and T-cell lymphoma indications
.
In addition, during the new release cycle, 5 innovative drugs from local pharmaceutical companies such as Tuola, Jiachen Xihai and Shijian Biotechnology were approved for clinical trials
.
Among them, Zhongke Tuola announced on November 4 that the company's new small molecule inhibitors TR115 tablets and TR64 tablets with independent intellectual property rights were approved by the NMPA Drug Evaluation Center on November 4, 2022, and agreed to carry out clinical trials
for non-Hodgkin lymphoma and advanced malignant solid tumors.
On November 9, the company reported that its new small molecule inhibitor TR128 capsules with independent intellectual property rights were approved by the NMPA Drug Evaluation Center and agreed to carry out clinical trials
for advanced malignant solid tumors.
According to the company, TR128 is the third product approved by Zhongke Tuola to enter clinical trials recently after TR64 and TR115, and it is also an important milestone
on the road of new drug research and development of Zhongke Tuola.
Jiachen Xihai announced on November 9 that the company's new drug JCXH-211 injection has been approved by the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China to carry out phase 1 clinical trials, intending to develop the treatment of malignant solid tumors
.
JCXH-211 is a new drug encoding human interleukin-12 (hIL-12) based on self-replicating mRNA, which is the world's first cytokine-expressing self-replicating mRNA for the treatment of advanced solid tumors, and it is also the first time that a domestic mRNA biotechnology company has obtained IND approval from the US FDA
.
The Class 1 new drug ESG206 injection declared by Shijian Biologics has also recently obtained the implied license of a clinical trial of CDE to be developed for the treatment of B-cell malignant tumors
.
The company's previous press release said that ESG206 specifically targets an undisclosed B-cell-specific target, and no drug targeting this target has been approved by regulatory agencies worldwide for clinical treatment
.
Disclaimer: Under no circumstances does the information or opinions expressed herein constitute investment advice
to anyone.