The target of the non -patent medicine "breaking the situation" or the "lost person": Do not superstitize FIC

The target of the non -patent medicine "breaking the situation" or the "lost person": Do not superstitize FIC

Source: amino observation/Cai Jiu

For innovative medicines, the highest hall is undoubtedly the first in class (FIC).

FIC means the first innovative drug. It is the first new mechanism drug to treat a certain disease. This requires a lot of basic research work, and the whole process requires time, far exceeding your imagination.

Of course, the difficulty is proportional to the income. Under normal circumstances, the order of drug listing plays a key role in market share. The McKinsey Research Report pointed out that FIC drugs have obtained an average of about 45%of the market share.

Because of this, after the end of Fast Follow, domestic innovative pharmaceutical companies have stated that they must "carry" the FIC flag.

However, there are exceptions in everything. FIC does not mean "perfect" performance. Generally, there is still great room for improvement. As a result, there is the basis of the birth of Me Better and Best in Class.

ME Better has a certain advantage over the performance than the original drug; Best in Class is the one with the strongest combat effectiveness among all similar drugs.

It can be said that in a fierce market, FIC products are not insurance. Once his data cannot keep up, and the later party shows the possibility of "super -vehicle", FIC products will undoubtedly be stressful.

Right now, Anjin's FIC product KRAS G12C inhibitor Lumakras, which was just approved for listing last year, has begun to challenge.

/ 01 /

The hidden concerns behind the successful clinical data of the third phase: failed to extend the survival of patients

On May 28 last year, Lumakras, the KRAS G12C inhibitor of Ansin, was approved for listing by FDA. This is the world's first KRAS target drug, which has been approved to be listed, and the market is restless.

Understanding. As the first carcinogenic gene in human history, the RAS gene mutations are related to about 20%of the tumor, but it has always been difficult to patent medicine and is listed as the famous "non -medicine" target.

As Anjin won the Holy Grail, KRAS targets were completely broken, and it was inevitable that it was completely excited.

However, the reason why Lumakras is the first to break through is related to unsatisfactory clinical needs to some extent.

Generally speaking, a drug needs to be approved for listing through strict clinical clinical clinical. However, because there is a huge clinical without meeting the needs, the FDA is only based on the results of the CodeBream 100 of the phase I/II clinical trial of Lumakras I/II, and it accelerates its listing.

Accelerating approval is not once and for all. After listing, Lumakras needs to obtain "approval" through clinical three -phase data.

At the ESMO conference in September in September, Anjin announced the latest results of Lumakras's treatment of Codebreak 200 in Phase 3 clinical trials of patients with non -small cell lung cancer.

It seems that the result of CodeBream 200 is more positive, reaching the main end of the non -progressive survival period:

Compared with standard chemotherapy, Lumakras has significantly improved patients' progressive survival rates. After 1 year of treatment, the no progressive survival rate of the Lumakras group was 25%, and the value of the chemotherapy group was 10%.

However, in terms of the total survival period of the secondary end, the Lumakras treatment group was not optimistic, only 10.6 months; and the median total survival period of the patient's treatment group in the control group Dorixa was 11.3 months.

This also means that the Lumakras treatment team made face and lost. For tumor patients, the fundamental purpose of receiving tumor drug treatment is to extend the survival period, but Lumakras cannot achieve one goal, and the data looks not as good as chemotherapy group.

However, it does not recognize this set of data. Anjin believes that the design of this experiment does not have enough samples to discover the differences in OS, and the cross -medication after progress has also masked the clinical benefits of Lumakras.

But at present, Lumakras's future will still be full of variables.

On the one hand, Lumakras's monthly treatment costs are as high as US $ 18,000, while the monthly treatment costs of Dolixi are only 2,000 US dollars. Although the Dorcio needs intravenous injection and Lumakras can have a higher advantage of administration for oral administration, facing a huge price gap will obviously make Lumakras' sales under pressure.

On the other hand, the global KRAS G12C inhibitors are developed in many research products. Pharmaceutical companies such as Si. Once the latecomers come up with better clinical data, it will undoubtedly challenge the status of Lumakras's FIC product.

In fact, Lumakras has been challenged in the field of colorectal cancer.

/ 02 /

Colorectal cancer: combined therapy encountered challenges

The development of the KRAS G12C inhibitor, the expansion of indications is essential.

In terms of global perspective, the KRAS gene mutations mainly exist in non -small cell lung cancer, colorectal and pancreatic cancer, accounting for 25%, 40%, and 95%, respectively.

Although Lumakras takes the lead in the field of non -small cell lung cancer, it does not have a significant advantage in the field of research and development in other cancer species. At present, it is challenged in the field of colorectal cancer. In the competition of KRAS G12C inhibitors, Lumakras's biggest competition competes from Adagrasib of Mirati. At present, AdagraSib lung cancer indications have been submitted to the listing application.

At this ESMO conference, both companies announced early data for the KRAS G12C inhibitor combined with EGFR monoclonal treatment of colorectal cancer.

According to the data named CodeBreak-101 Subprotocol H released, the Lumakras combined with the ORR (objective relief rate) of the Peni monoclonal resistance was 30%, and the efficacy of the single drug was greatly improved (ORR was 9.7%).

However, Adagrasib looks stronger. Mirati's research released by Krystal-1 showed that Adagrasib single drugs and combined therapies ORR reached 19%and 46%, respectively.

Considering that patients in the Adagrasib trial have tried three -line treatment before, and Lumakras' research has only two -line treatment, and the results of Mirati seem to be better.

In addition to Mirati, another challenger is Roche. According to the data released by Roche, its KRAS G12C inhibitors GDC-6036 obtained 20%of ORR in dosage climbing, and subsequent data is obviously worthy of attention.

Of course, the three companies published in the field of colorectal cancer are early clinical data. Whether it can maintain the current advantage in the future takes time to give the answer.

But anyway, Lumakras's advantage as FIC products is not so stable.

/ 03 /

To open the door for competitors, "FIC" products are also under pressure

As the world's first KRAS G12C inhibitor, Lumakras, Anjin, undoubtedly comes with star halo. The launch of Lumakras has also triggered the R & D boom of the KRAS G12C inhibitor.

However, the halo of Lumakras seems to be dull. In fact, this has long been reflected at its sales data.

In the first quarter of 2022, Lumakras's sales in the United States reached $ 48 million; but in the second quarter, the product was only US $ 51 million in US sales, and the growth rate was less than 7%. Slowly slowly.

In fact, SVB securities analysts believe that if the product's US price rose 3%on July 1, Lumakras's sales may be lower, because price increases will promote some wholesalers to buy in June in June.

Because of this, SVB pointed out that Lumakras's performance is much lower than market expectations. Based on this, SVB analysts also lowered Lumakras' annual sales to US $ 326 million, and Wall Street's forecast was $ 347 million.

It was not surprising that Lumakras began to show the slump in the second quarter. Although Lumakras shot the first shot of the KRAS G12C inhibitor, the data was not perfect.

At that time, in the two -year follow -up analysis, the objective relief rate of 174 patients was 40.7%. Compared with the previous improvement, it was still not a "ceiling". To some extent, side effects also limited the use of Lumakras.

Earlier, SVB analysts believe that the reading of subsequent clinical data will become the key to whether Lumakras can stand firm.

Today, with the disclosure of the latest clinical data of the third phase of "pulling down", it will inevitably further cause market concerns. As mentioned above, the latecomers are influxed into the KRAS G12C market, and Lumakras will inevitably encounter the challenge of the latecomers.

Although the FIRST-IN-CLASS products are very attractive in both the achievement or the market. But in the end, the value of the product itself must be returned.

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