[Transfer] Cake Examination Fatigue: The clinical success of the third phase, the product is approved?

[Transfer] Innovative drugs secondary market Cake fatigue fatigue: the third phase of clinical success, the product approved, it is not used.

Source: amino observation/Lin Xiaochen

In the past few years, under the capital bubble, the most popular field of innovative drugs is undoubtedly PPT wealth:

A more than 20 pages of PPT, a few brilliant returnees, a bluffing product pipeline map, one by one to VC projects, continuously financing, and then successfully listed on the status of "innovative medicine" and moved towards life to life. peak……

In essence, this is the only way for domestic innovative medicines to go from scratch. After experiencing heavy poisoning, the domestic market has also begun to mature. At least in the secondary market, everyone becomes more and more "picky".

In the past, the clinical clinical of product declarations can also cause investors to discuss extensively; but now, the third phase of clinical success is successful. Even if the product is approved to be listed, Biotech's stock price may not respond.

Everyone, no rabbits at the beginning, no eagle?

/ 01 /

More and more cautious secondary market

Innovative pharmaceutical companies have died their lives. In this industry where only a few people can survive, the biggest certainty is the clinical success of the product or approved to be listed.

In the U.S. stock market, products are approved or clinically successful. This was the case in China before, but gradually, the good news of the market's approval of the market began to be immune.

The recent example is Ou Kangwei, a Hong Kong stock listed company. On June 20th, the new drugs (OT-401) of the fluorochinated vitrum introduced by Oukang Vision were approved for the listing of steroid implants in China for the treatment of uveitis in China.

The approval of such a product is also good for the company. On the first day of the approval, Oukang Vision's stock price rose 8.16%, and the second trading day rose 5.92%.

But it is difficult to say that the rise is completely due to product factors. On June 21, Hang Seng Biotechnology ETF increased by 4.07%. On June 22, the market had recovered, and Oukang Vision Biological also plunged 8.64%, almost smoothed up the rise of two trading days.

Not only in Hong Kong stocks, the same is true of science and technology boards. On June 21, Zeye Pharmaceutical announced that Jak inhibitors Jack Tyini Tablet was treated with high -risk bone marrow fibrosis phase III clinical trials to complete the preset intermediate analysis. Clinical trials reach the main end of the preset.

This is the first successful clinical clinical clinical of Zezhe Pharmaceutical JAK inhibitor. The company stated that it will communicate with the CDE before listing.

Jackin's clinical progress has also received the attention of seller researchers. For example, Southwest Securities gave Zezhe Pharmaceutical holding rating, saying that "Jackinib NDA is imminent, and the pipeline is accelerated."

But in the secondary market, "indifferent". Whether it is June 21 or 22nd, Zeye Pharmaceutical Pharmaceutical's stock price has been slightly closed.

Obviously, the market has changed.

/ 02 /

Success of R & D ≠ commercialization of commercialization

This is not surprising. Product development is only the first step of success. In the future, there are commercialized examinations waiting for Biotech to break through the barrier. With reference to the competition of PD-1, it is not uncommon for domestic innovative pharmaceutical companies to open and low.

Back to Oukang Weiwan, the market is becoming more and more cautious.

As the country's first drug approval based on real-world data, investors do not have to doubt the efficacy of OT-401 OT-401, but this does not mean that OT-401 will definitely be sold.

In the US market, Eyepoint's yutiq is not a particularly successful product. The sales of Yutiq in 2021 were only $ 16.959 million. Satisfied.

Yutiq's commercialization is not good, and the market mainly attributes it to two major factors: the market is too small and competitive.

Throughout the United States, the total number of patients with uveitis is about 300,000. Among them, there are fewer patients with possessoritis, which may only be more than 100,000. In such a small market, Yutiq also faces the competition between two other steroids and Ozurdex, so in the US market, Yutiq's status is not high.

Many domestic investors see the reasons for more Yutiq. This is also here. There is no situation that the Chinese market does not have those restrictions on Yutiq. Therefore, it is likely to become a big explosion after the introduction of Oukang Wei.

On the one hand, the market size of uveositis in China is 10 times that of the US market; on the other hand, as the first approved steroid implants in China, Yutiq is expected to enjoy this blank market.

If the sales of YutiQ in the US market are calculated, the OT-401 is expected to become a product with sales exceeding 1 billion yuan. But will things really go so smoothly?

First of all, steroid implants are not irreplaceable, and it can only be regarded as an upgrade therapy at best. Without considering costs, the performance of steroid implants is significantly better than corticosteroid drugs in terms of compliance and efficacy.

However, if you consider economic factors, the cost performance of OT-401 will be greatly reduced. Traditional corticosteroid drugs may cost more than 100 yuan per month, and the cost of OT-401 has a magnitude of magnitude.

With reference to the price of YutiQ in the US market, the market is generally expected to sell for OT-401 from 50,000 to 60,000 yuan. For American families, the expenditure of $ 3,000 per year is not high, but for domestic patients, the expenditure of nearly 20,000 yuan per year is still a high price. From the market level, how many patients are willing to pay for this limited improvement, which is still unknown. Perhaps this is why Oukang Vision's first product was approved to be listed, but the attention was not high.

Zezheng Pharmaceutical also encountered the same problem. On June 21, Zeye Pharmaceutical disclosed that the core pipeline hydrochloride hydrochloride treatment of medium and high -risk bone marrow fibrosis III clinical trials reached the main end of the test, but the market did not give any response. The core reason was that the market was too small to be too small It's right.

In 2020, there are only 61,000 patients with bone marrow fibrosis, and they are also divided into low -risk, medium -danger level, level 2 and high -risk patients. In other words, the currently successful indicator of Jackinib is less than 60,000.

Although in the current Chinese market, the effective treatment of bone marrow fibrosis is scarce, and only imported drugs are approved. But Jackinib has been approved several times, and domestic alternatives are also very limited.

Such a case tells us that the success of the R & D level is only the first step of Biotech Long March. After the success of the product is promoted to the market, commercial progress will be the key to the next step.

/ 03 /

From virtual to real, the return value of innovative drugs itself

The changes in the secondary market preferences are essentially a change from virtual to real.

From the initial project disputes in the domestic innovation medicine industry, to the later differentiated battle, and then to the later clinical data disclosure, it was finally rolled into commercial progress.

This can also be understood. The value of the pipeline only represents the expectations of one product. Before the product is listed, the market may give the star pipeline high valuation for various reasons, but this valuation does not have real value.

When it is expected to be difficult to fulfill, only Biotech's ultimate commercialization capabilities can really impress the market. This has been shown in the first echelon BIOTECH company.

For BIOTECH, only by selling data can it prove the actual value of its own pipeline. In addition, no matter what sales predictions are given by analysts and institutions, they are not convincing.

In the business world, all the standards for assessment will be cold sales numbers. In the process of commercialization of the product, every link and details of sales teams, advertising marketing, and product efficacy may make the situation of a Biotech company change suddenly.

For example, a large number of companies that followed the wind and developed PD-1 pipelines, although the fieryness of the PD-1 concept has been sought after, but with the mainstream PD-1 succession, it is difficult for those pipelines that have not completed the clinical line. Fate of escape failure.

If the previous biopharmaceutical market was hot and a large number of players poured into the market, then as the market continued to evolve, these companies that did not have market competitiveness would gradually withdraw from the historical stage.

In the past, the way of financing by pipeline stories was gone. Instead, it was replaced by products that really have commercial value to break through the siege.

As the products of the second echelon BIOTECH are listed one after another, the market is about to start a commercialized examination for them. The funds in the hot field are like a double -edged sword. On the one hand, the development of biopharmaceuticals is promoted, and on the other hand, it has made pharmaceutical companies beginning to become impetuous.

When the funds are ebb, only pipelines with real commercial value can break through the obstacles. Only enterprises that really researched can re -obtain market recognition. Perhaps this is the original intention of the "doctor".

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