[Transfer] From the treatment of AIDS to R & D developers, the rolling king PD- (L) 1 breaking way

[Transfer] From the treatment of AIDS to R & D developers, the rolling king PD- (L) 1 breaking way

Source: amino observation/Fang Taozhi

Once upon a time, in the face of PD- (L) 1, the big item that did not meet for the century, the market was extremely optimistic. It is expected that the domestic market size can reach 100 billion.

But the swarming pharmaceutical companies changed the development trajectory of the PD-(L) 1 market. The once -100 billion market dream was replaced by cruel inner rolls.

However, PD- (L) 1 is so internal, which also illustrates the improvement of the innovation strength of the domestic pharmaceutical industry from the side. This is worthy of recognition.

What is more worthy is that even so, the latecomers still did not completely give up PD- (L) 1, but instead use them to find out a rolling way:

Find the incremental market from differentiated indications, use PD-(L) 1 monoclonal anti-anti-anti-antibody to treat hepatitis B, AIDS, and make a film. (L) 1 ...

You roll you, as long as your mind does not decline, the method is always more difficult than.

/ 01 /

The annual treatment fee fell below 40,000 yuan, there was no most rolling, only more rolling

In the domestic innovative medicine track, the most crowded track is PD- (L) 1.

As of now, there have been 13 models have been approved for listing PD-(L) 1, including 7 domestic PD-1, two domestic PD-L1 models, and 2 models of imported PD-1 and PD-L1.

This is not over yet. According to Anxin Securities forecast, 17 PD- (L) 1 will be listed in China by the end of 2022. No wonder some people say that PD- (L) 1 production capacity is so much that can be used for bathing.

As the number of shortlisted players continues to increase, the price wars of each family are in full swing.

In this regard, we can refer to the price change of the first domestic PD-1 Junshi biological Treepley monoclonal resistance. In 2019, Tripley Mipide was priced at 7200 yuan/240mg.

Based on this price, the annual treatment cost of a patient with a weighing 60kg of patients with a weighing patient was about 187,200 yuan. Under the conditions of meeting the medicine, the annual medication cost could be reduced to 93,600 yuan.

Today, how much is the price of the PD-1 of Junshi creatures reaching? The answer is 82%.

With the new version of the medical insurance catalog in 2022, the price of Tripley's anti -scoring price dropped to 1912.96 yuan/240mg. Under the same conditions, the annual treatment cost was about 33,200 yuan.

The newly approved PD- (L) 1 product, the price is directly fractured. For example, the Kangfang Biological/Zhengdian Qingqing PD-1 monoclonalist Apeli, through the drug gift plan, the cost of capacity was as low as 39,000 yuan in two years.

So, is the price battle of PD- (L) 1? Maybe not, because there will be more and more players who enter the game next.

No way, although the price has been fractured, PD- (L) 1 still has room for imagination. Because in addition to single medicine, combined can also develop the market. PD- (L) 1 can be said to be the cornerstone of immunotherapy. Just like the West, there must be no Jerusalem, and pharmaceutical companies with great great magic can not be without PD- (L) 1.

In other words, the battle of PD- (L) 1 in the volume is unavoidable. In this case, it is not as good as the survival of the fittest. Pharmaceutical companies have shown their magical powers from all over the sea, trying to find their own way of survival on the PD-(L) 1 battlefield.

/ 02 /

Treat hepatitis B, treat AID

On the PD- (L) 1 battlefield, the point of "those who adapt the symptoms" are long-term talk.

From the beginning of the birth, the dispute between the two elder brothers K medicine and O drugs has not stopped. At present, whether it is the victory K medicine or the defeat O, it is still expanding the scope of indication.

Not long ago, O drugs added two new esophageal cancer indications in China, becoming the first PD-(L) 1 inhibitor in China that covers esophageal cancer assist therapy and advanced first-line treatment at the same time.

Not only Os and K medicine, but also domestic PD-(L) 1, including Baiji Shenzhou, Cinda Bio, Hengrui Pharmaceutical, Junshi Bio, etc., but also continue to broaden indications.

For other latecomers, the pressure is undoubtedly greater. Last year, CDE released the "Principles of the Clinical R & D Guidance of Anti -tumor Drugs", which mentioned that the development of new drugs should think that patients provide better treatment options as the highest goal. This means that the latecomer wants to compete with the same indications with the old players, and it is indispensable to test.

Even if it can challenge success, the commercialization ability of BIOTECH in the same indication may be far less than the first PD-(L) 1 four dragon that can be taken first. The market that can be seized is very limited.

In this case, many players began to take a different approach. Since the path of PD- (L) 1 is too crowded against the tumor, we can choose non-cancer indications for changing the road. As the so -called big road through Rome.

That's right, PD- (L) 1 can not only be used to treat tumors, but also the potential to deal with other diseases.

For example, the PD-L1 monoclonal ASC22 of the Gery Pharmaceutical, the indication of the aiming is hepatitis B and AIDS. Among them, the clinical trials of hepatitis B have been conducted in the second phase of the clinic, and the clinical trial for AIDS completed the first patient on July 4.

Of course, whether it is hepatitis B or AIDS, it is recognized in the world that it is difficult to overcome diseases, commonly known as the development of black holes. It is self -evident to choose to challenge these two indications. Whether it can succeed in the end is still unknown.

Unlike the Gery Pharmaceutical, the goal of the wisdom nuclear creature is to develop a developer.

Smart nuclear biology has developed a radioactive developer drug of the 68GA marker PD-L1, which can connect PD-(L) 1 antibody with the same plain puppets to detect the level of PD-L1 expression level of various organs of the whole body. "Volume Soldier".

At present, this product has been declared in China and the United States. Can the road of the optic agent allow the wisdom nuclear creature out of the PD-(L) 1 Red Sea? Let us continue to observe.

All in all, on the road of breaking through the internal roll through differential adaptation layout, domestic pharmaceutical companies, you have Zhang Liangji, I have a wall ladder, and the pattern will open.

/ 03 /

Inject from subcutaneous injection to oral drugs, the road of dosage upgrade

In addition to working on the adaptive symptoms, some players choose to make articles on the dosage form.

The current PD-(L) 1 inhibitor that has been published requires intravenous injection. The insufficient intravenous injection preparation is that it is not convenient to use, the incidence of side effects is high, and the patient's blood vessels are high. This allowed the latecomers to see the rolling way -upgraded dosage form.

For this reason, Di thought of developing subcutaneous injections. Compared to venous injection, the subcutaneous injection type is more convenient. It only takes tens of seconds to complete the administration. In this way, it will not stimulate the blood vessels of the patient.

In November last year, the PD-1 monoclonal anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-company industry was sold. In this regard, Huatai Securities is expected to reach 1.7 billion yuan due to the advantages of the dosage form.

Although the securities firms are full of confidence, it is not easy for the idea of ​​Di/Xianyin Pharmaceutical to achieve this goal, because in addition to the subcutaneous injection, the oral dosage type is also jealous.

Compared with subcutaneous injection preparations, oral preparations are more convenient and can completely get rid of tedious procedures such as registered infusion. If oral preparations can be successfully developed, it will undoubtedly make the cancer chronic disease closer.

In addition, oral PD- (L) 1, as a small molecular drug, can achieve lower costs, and has a natural advantage at the price-side oral preparation. At present, domestic pharmaceutical companies including Beda Pharmaceuticals have entered the field.

Of course, it is not easy to develop from injection preparations to oral preparations. For example, in the small molecular field, Biotech Incyte, which has strong strength, has encountered severe safety problems in clinical clinical clinical clinical clinical. Therefore, there are still many uncertain factors whether oral preparations can really land.

But anyway, the road of domestic pharmaceutical companies also provides us with an observation window. Even as the king, PD- (L) 1 is not impeccable, and there is still a way to go.

Whether it can be successful in the end, but the spirit of the bravery of pharmaceutical companies is undoubtedly worthy of recognition.

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