Sales in 2021 will remain strong. What is the magic of the HER-2 target of the TOP10 clinical numbers last year?

Roche released its third quarter report for 2021 at the end of October.

Although trastuzumab's sales declined year-on-year due to a large number of biosimilar drugs occupying market share globally, the approval of the subcutaneous injection of Pertuzumab and the adjuvant therapy indications of enmetrastuzumab led to the approval of these two drugs Sales increased year-on-year
.

Domestic research and development of HER-2 target remains high

In the latest CDE "Annual Report on the Current Status of Clinical Trials for New Drug Registration in China (2020)", the HER-2 target ranked 8th in all dimensions of statistics last year, which is sufficient to illustrate the research and development of HER-2 targets in China The homogeneity is serious
.

Figure 1 The distribution of the top ten targets and indications of Chinese drug varieties in 2020

Data source: "Annual Report on the Current Status of Clinical Trials of New Drug Registration in China (2020)"

Figure 2 The top ten targets and trial stages in the number of registered clinical trials in China in 2020

Data source: "Annual Report on the Current Status of Clinical Trials of New Drug Registration in China (2020)"

Global HER-2 targeted drug indication pattern

Since the listing of trastuzumab in 1998, there are currently 11 targeted drugs on the market worldwide, including 4 macromolecular monoclonal antibody drugs, 3 ADC drugs, and 4 small molecule TKIs
.

Among the several drugs newly marketed in the past two years, domestic HER-2 targeted drugs are mainly used as effective alternatives to domestic products, and the three newly listed foreign drugs are mainly targeted at patients with breast cancer after the final resistance.
This is mainly due to Advanced breast cancer has gradually developed into a chronic disease, and there are more and more patients with drug resistance under the existing treatment methods
.

At present, as far as the indication coverage of marketed drugs is concerned, China has basically covered the treatment of advanced gastric cancer and breast cancer, and the main problem currently faced is still the problem of drug resistance
.

For products under research, there are fewer types of HER-2 under research in foreign countries, and the indications are no longer concentrated on gastric cancer and breast cancer.
Breast cancer types are also mainly aimed at early adjuvant treatment and late-line treatment after drug resistance.
; And the focus of China's research and development is still focused on the fields of currently marketed drugs.
For the domestic replacement of early breast cancer and the clinical gap after advanced breast cancer resistance, there are basically no varieties under research, and the phenomenon of research and development is serious
.

Involved market for HER-2 targeted drugs in China

Since both trastuzumab and lapatinib entered medical insurance through negotiations in 2017, 5 of the 8 products currently on the market have undergone medical insurance negotiations, with an average drop of 63.
8%
.

In an environment where prices are gradually "involved", how to price newly listed products has become a major problem that plagues companies, and it also has a great impact on the bargaining power of medical insurance negotiations
.

With the increasing number of newly listed drugs and the impact of numerous generic or biosimilar drugs on the market after the expiration of imported drug patents, it is believed that the overall price of HER-2 targeted drugs will continue to decline
.

From the perspective of sales data, the overall market space for the sales of HER-2 small molecule TKIs is relatively small, and the growth will still be relatively slow when there are new drugs on the market in 2020
.

A differentiated R&D structure can ensure the healthy development of the pharmaceutical industry

As China's pharmaceutical R&D has leaped from the previous third echelon "following" to the second echelon "parallel running", the long-term development goal of China's pharmaceutical industry has shifted to the first echelon
.

Through the comparison of research and development status at home and abroad, it can be found that the research and development enthusiasm of HER-2 target in the international market has gradually receded with the listing of many targeted drugs, but Chinese companies are still fiercely competing in this mature environment of research and development

In response to this phenomenon, the capital market and policies have begun to exert force.

I believe that under the guidance of policies and the adjustment of the market, China’s pharmaceutical R&D landscape will gradually move towards differentiated competition.
Only in this way can Chinese companies blaze a trail in an increasingly competitive environment, and only obtain over-centralized clinical resources.
With reasonable and effective distribution, the Chinese pharmaceutical market can leap to the first echelon of "leading"
.