Entering the post-medical reform revision stage, pharmaceutical companies need to strengthen innovation and actively deploy overseas

【Pharmaceutical Network Market Analysis】Under the background of the normalization of centralized procurement, drug price reduction has become a trend
.
Since 2019, China has completed the implementation of six batches of state-organized drug collective procurement results, and November this year is the month when the seventh batch of state-organized drug procurement results in most provinces and cities landed, with a total of 60 kinds of drugs collected this time, with an average price reduction of 48%.

At present, the total number of drugs collected by the state has reached 294, covering common and chronic diseases such as hypertension, coronary heart disease, diabetes, as well as drugs for major diseases such as lung cancer and breast cancer, and the average price of drugs has decreased by more than 50%, greatly reducing the burden of
drug costs on patients.
From the perspective of price reduction, the price reduction of the seventh round of drug centralized procurement seems to have eased compared with previous rounds, but the trend of innovation under the pressure of generic drug profits still forces traditional pharmaceutical companies to accelerate innovation and transformation
.
At the same time, with the acceleration of the launch of innovative drugs, the national medical insurance negotiations have also entered the normal, for pharmaceutical companies, although innovative drugs into medical insurance can achieve volume, but also face the risk of price reduction after medical insurance negotiations, as well as the challenge
of fierce competition on the track.
Taking anti-tumor PD-1 and PD-L1 inhibitors as an example, in recent years, PD-1/PD-L1 research and development has been hot, and the track has become more and more crowded, and many PD-1 and PD-L1 have not hesitated to reduce prices in order to squeeze into the medical insurance directory to achieve price exchange for volume and seize the market, which also aggravates
the phenomenon of "involution".
With the increasing homogenization, PD-1/PD-L1 R&D companies have to try new outlets, often by increasing the layout of indications and broadening the scope of applicable patient populations, so as to horizontally expand the market scope
.
For example, on November 1, Henlius announced that serplulimab (commonly known as "H drug") has been approved for the second indication of a combination of carboplatin and albumin paclitaxel for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer
that cannot be resected.
In March this year, the first indication for the approval of drug H for the treatment of highly unstable microsatellite (MSI-H) solid tumors
was approved.
In addition, the marketing applications for two new indications of drug H for the first-line treatment of small cell lung cancer and esophageal squamous cell carcinoma were successively accepted
by the NMPA in April and August this year.
In the United States, for the indication of extensive-stage small cell lung cancer, Drug H (small cell lung cancer) has been granted orphan drug designation by the US FDA, and Henlius plans to submit a marketing application
for this indication in the United States in the first half of 2024.
According to the company's semi-annual report, as of June this year, the H drug that has just been listed has shown good business prospects and achieved sales revenue of 76.
9 million yuan
.
In June, Bristol-Myers Squibb announced that the PD-1 inhibitor Odivo ® (nivolumab injection) was approved by the China National Food and Drug Administration to add two new indications for esophageal cancer: adjuvant therapy for patients with esophageal cancer or gastroesophageal junction cancer who still have pathological residues after neoadjuvant chemoradiotherapy (CRT) and complete surgical resection; Combined fluoropyrimidine and platinum-based chemotherapy is indicated for first-line treatment
in patients with advanced or metastatic esophageal squamous cell carcinoma.
Previously, nivolumab injection has been approved in China for 7 other indications
.
In addition to increasing the layout of indications, many pharmaceutical companies are actively deploying overseas markets, especially the US market, in order to inject impetus
into the subsequent growth of products.
For example, BeiGene, which went overseas earlier, is the first domestic BTK inhibitor to be listed in China and the United States, and the product has been approved in more than 50 markets, and there are still more than 40 marketing applications outside the United States, China and the European Union, involving more than 30 countries and regions, and the future market space is huge
.
Compared with imported products, BRUKINSA also has the advantage of low price and cost, coupled with the international layout, the industry expects that the peak sales of this drug may exceed 100 US dollars
.
It is worth mentioning that for pharmaceutical companies that want to expand overseas in the future, the US FDA has made new deployments and tightened the new drug review policy, and the industry expects that PD-1 or PD-L1 drugs declared for marketing with Chinese patient data may face the risk of being cut off, and how to go overseas in the future is a problem
that pharmaceutical companies need to spend more effort on research and exploration.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice
to anyone.