[Transfer] Termid SERD research and development, 8 billion US dollars to the end?

[Transfer] Sanofi terminated orally with tears, and the 8 billion US dollars came to an end?

Source: amino observation/Fang Taozhi

Preparing for clinical failure at any time is the basic literacy of research and development of innovative drugs. After all, the story of the new medicine has been developed for nine deaths, and we have seen too many times.

Now in the field of oral Serd (estrogen receptor degradation) in the drug factory, it has been verified again.

A few days ago, the clinical failure of Sanofer's oral Serd AMCENESTRANTANTANORAN. This is another defeat after the clinical failure of the single medicine in March. Based on this, Sanofi decided to stop all AMCENSTRANT's clinical trials.

This means that Sanofi completely admits defeat in the field of orally. In fact, Sanofi is not the first pharmaceutical factory to lose in the SERD field, nor is it the last one.

Roche's oral SERD also showed signs of danger. In April this year, it was taken over a clinical defeat. Failure to fail, the future of oral SERD is full of fog.

Will this be persuaded in China, including Yifang creatures, Shandong Luo Xin, Zhejiang Haizheng, and Zhengteng Biotechnology, etc., and hope to enter the game?

/ 01 /

"Ideal" Nuggets

Oral SERD's attention can be understood by the attention of pharmaceutical companies. After all, it has the largest subtype of breast cancer indications-HR+ / HER2-, up to 68%.

The so -called HR refers to estrogen receptor. When the surface of the cancer cells expresses estrogen receptors, it can be defined as HR+.

Estrogen receptors can regulate a variety of physiological processes, such as cell growth, proliferation, development, and differentiation. When the estrogen receptor is used by cancer cells, it becomes the "accomplice" of cancer cell proliferation. Therefore, the estrogen receptor on the surface of the cancer cells can be degraded or suppressed, which can inhibit the growth of tumors.

The main treatment method for HR+ / HER2-breast cancer is endocrine therapy. Although selective estrogen receptor degradation (SERD) is not the first choice, the status is pivotal and the market size is not small.

There is only one fluoros group approved by SERD drugs. The sales of patents exceeded 1 billion US dollars before the expiration of patents, and successfully ranked among the heavy bombs. But the disadvantages of Fluowis Group are obvious:

First of all, the method of administration of Fluowis group is muscle injection, which needs to be injected every month to be injected. The patient's compliance is poor;

Secondly, the currently approved dosage of Fluiwi group is 500mg. The use of higher doses of Fluivzi group may achieve better estrogen degradation. possible.

Finally, the effect of Flui Siqun to patients with ESR1 mutations is not good.

Therefore, if the shortcomings of the Fluvis group can be improved, and the development of oral SERDs with higher biological utilization and stronger receptor degradation ability will inevitably get a generous return.

Earlier, Jefu Rui analysts predict that if the oral SERD can be successfully appeared, the market value of such drugs is at least 7 billion to 8 billion US dollars.

The same is true, Sanofi, Roche, Astraco, and Eli Lili have joined the study of oral SERD.

/ 02 /

The giant slaughterhouse in reality

However, the ideal is full and the reality is very skinny. Today's oral SERD not only fails to make the giants nuggets, but has become a buried place for giants.

The most severe loss on oral SERD is the big pharmaceutical company Sanofi.

In March of this year, Sanofi announced that compared with single-drug endocrine therapy, Serd oral medication AMCENESTRANT treats HR+/HER2- local advanced or metastatic breast cancer II clinical research, which failed to reach the main endpoint of no progressive survival period. Essence

However, the clinical defeat at the time did not completely sentence AMCENESTRANT's future. Although the single medicine failed, there is still the life -saving straw.

Sanofi said that it will also explore the efficacy of AMCENESTRANT in different tumors and early breast cancer patients with different standards.

The good times are not long. On August 17th, Sanofi announced that in the third phase of clinical trials named Amera-5, amcenestrant combined with CDK4/6 inhibitors PalboCiclib, which failed to reach the predetermined boundaries of use use in advanced ER+/HR2-breast cancer patients Essence

This is also an end to AMCENESTRANT's research and development. Sanofer is discouraged and will stop AMCENESTRANT's global clinical development plan.

For Sanofi, the impact of AMCENESTRANT's failure of research and development is not great. After all, AMCENESTRANT is one of the six products developed by Sanofi, and it is also regarded as the potential pressure cockpit stones of the Sanofi tumor tumor.

Now, in the future, the ballast of the cockpit has been collapsed, and the stock price of Sanofi has also plummeted. As of August 17, the stock price of Saifei fell 5.87%.

Sanofi was not the first loser in the field of oral SERD. Prior to them, Aisleykang, Hengrui Pharmaceutical and other pharmaceutical companies had disappeared.

It will not be the last loser. Coincidentally, in April of this year, Roche revealed in the first quarter financial report that the SERD drug Giredestrant failed to reach the main end point of improving no progressive survival in the Phase II clinical trial of breast cancer. Roche did not cut off the Giredestrant pipeline because of this failure. At present, GiredESTRANT is conducting two other phase III tests. One is the first treatment of metastatic breast cancer with Pfizer's Berosley, and the other is the treatment of early breast cancer.

Once the failure of failure was ahead, the shadow of the failure of the stack of Sanofi undoubtedly made Giredestrant's future confusion.

/ 03 /

The winner also found nothing

Of course, there are also successful examples of oral SERD drug development, but it is also "accidental".

In December 2021, Radius announced the clinical data of oral SERD drug Elacestrant:

Among the general population and patients with ESR1 mutations, compared with the standard treatment group, Elacestrant has extended the patient's median no progressive survival period from 1.91 months to 2.79 months, which reduced the risk of disease progress or death by 30%;

Among the patients in the ESR1 mutation Asian group, compared with the standard treatment group, the mid -level no progressive survival period has been extended from 1.87 months to 3.78 months, and the risk of disease progress or death is significantly reduced by 45%.

Elacestrant has submitted a new drug listing application to the FDA in June to treat patients with ER+/HER2-advanced or metastatic breast cancer.

Although ElaceStrant became the first oral SERD drug that was higher than Fluori group, investors did not buy it. After Elacestrant clinical data was announced, Radius's stock price fell 44.3%.

Because of the patients in the group, ElacedStrant requires extremely harsh requirements, and patients need to receive 1-2 line endocrine therapy, and the number of chemotherapy is less than once.

Among the patients in the group, 47.8%of patients carry ESR1 mutant patients, which may cause ELACESTRANT to only be used for patients with ESR1 mutations on the indications.

This part of the patient group is much smaller, so the imagination space of Elacestrant is greatly reduced.

In addition, from the perspective of clinical data, although Elacestrant has reached the clinical end, it only brings the patient's survival extension for less than one month in the general population. For patients, it is questionable whether this has clinical value.

In June this year, Radius was privatized for $ 890 million. It seems that even if Elacestrant seizes the first -mover advantage, the strength is not hard enough to let investors recognize.

/ 03 /

How to get away from the latecomers?

Although oral SERD drugs are full of variables, there are still many players waiting to go.

Overseas, Azd-9833 and Lyli Lyli Ly3484356 have started three phases of clinical research. In the country, Yifang creatures with rapid research and development progress have also entered the clinical period.

However, for these players, do you have to face a realistic problem, is there still the future of oral SERD?

From the perspective of research and development, although Sanofi's folding halberd does not mean that he has drawn a question mark for oral SERD. But for the latecomers, it is bound to be very embarrassed.

For many pharmaceutical companies, it is also a question that requires deep thoughts like Radius, or persist in the end like Robe and Sanofi.

Take a step back, even if oral SERD can be listed in the country, its subsequent commercial expectations must draw a question mark.

The reason is that the patent period of Flui Si group has passed, and the imitation drugs of the domestic Da Tianqing and Haosen Pharmaceuticals have been listed one after another. The advantage of oral SERD is not greater than that of Fluori.

The effect, at present, the effect of the first success ELACESTRANT is not much higher than that of Fluoris group. In this case, patients are willing to choose a 85 -point product with a better price, or they are willing to choose a 90 -point high -priced product. The answer is unknown.

It is necessary to be hard to hit the iron. The future of oral medication is still depends on how much pharmaceutical companies can improve their oral SERD effects.

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