The Dilemma of Innovation: From the PD(L)1 track to see the innovation choices of Chinese local leading companies

Text | Yichun Yiqiu

"Double reduction", "School District Housing Reform", "Clinical Value-Oriented Drug Development", "New Coronavirus Mutant".
.
.
Under intensive regulation, the secondary market has responded very strongly.
It is precisely in this context that we continue to move forward.
China's development is undergoing great changes, especially in China's pharmaceutical innovation!

In terms of the general >
.

Under the new pattern of regulatory review, investment and financing, clinical development, and market payment in China's innovative drugs, how to overcome the difficulties of innovation? The innovative development of various pharmaceutical companies are also trying to submit different answers.
This article is based on the PD(L)1 competition.
Tao’s competitors initially discussed this issue
.

The homogeneity of PD(L)1 monoclonal antibody competition is fierce,

The second tier 7 varieties are ready to go

On August 5th, China's NMPA approved the 5th local PD(L)1 monoclonal antibody, which is annikol (Pianprizumab) jointly developed by Kangfang Bio and Zhengda Tianqing for second-line and above recurrence Or refractory classic Hodgkin's lymphoma, which officially opened the prelude to the market competition of the second echelon 7 varieties
.

PD(L)1 monoclonal antibody of the second echelon in China: Anike leads the way

As of August 8, 2021, *the drug has been approved for marketing

According to rumours, Anike’s price is 4875 yuan/bottle, specifications: 100mg/10ml/bottle, and 1 course of treatment is available for free.
Follow-up will adopt the “2+1” and “2+PD” drug-giving policy
.
For classic Hodgkin's lymphoma, 200mg/time, Q2W, which means that the total treatment cost of PD(L)1 tumor immunotherapy is about 40,000 yuan! This is comparable to Duboshu's medical insurance pricing!

40,000 RMB/2 years, with an average of less than 2,000 RMB a month, the price of latecomers on the same indications is difficult to break through this top line, and there is still room for price decline
.

But how big is this space? Maybe 50%!

PD(L)1 is a fulcrum,

How can we leverage tumor immunity?

Regardless of China or Europe and the United States, tumor immunity is of course a big market, and PD(L)1 is of course a huge fulcrum
.

As mentioned above, the second echelon of China's PD(L)1 has 7 local varieties, but did you know that there are still 5 PD(L)1 in the current phase 3 clinical phase, plus two double antibodies
.
Low-level repetitive competition is especially obvious on the PD(L)1 track!

PD(L)1 is a fulcrum, how can we leverage tumor immunity? The answer of the Chinese variety is: you must cut into the track, in any case, you must follow, even if it is now we-too; speed up the pace of listing, use small indications to cut in as soon as possible
.
Hodgkin’s lymphoma, peripheral T-cell lymphoma, MSI-H or dMMR solid tumors have become the most popular first approved indication for tumor immunity in China.

Picture: China/U.
S.
has been approved for listing or the first approved indication for a variety in the market review stage

Therefore, when there is no room for competition between the above two options, China's tumor immunity competition landscape will usher in new changes, and it is now at such a moment
.
The following will try to describe the so-called changes from a corporate perspective for readers to discuss

Junshi Biology, Xinda Biology, Hengrui Pharmaceuticals, and BeiGene form the first echelon of China's tumor immunity.
Such varieties include domestic Chinese varieties that have been approved for marketing during the year from December 2018 to December 2019
.
This type of species is currently working in two directions: to expand China's high-incidence tumor types, such as lung cancer, stomach cancer, liver cancer, nasopharyngeal cancer, etc.

Layout of high-incidence tumor types in China: Teriplimumab has made a major breakthrough in nasopharyngeal carcinoma

After the local varieties were quickly approved for listing, of course, they all have a layout in the high-incidence tumor species in China.
I personally think that the breakthrough of teriprizumab in nasopharyngeal cancer is the most worthy of attention.
This is also one of the few local varieties that leads the world.
breakthrough!

According to statistics, there are about 120,000 new cases of nasopharyngeal cancer in the world.
China faces a high burden of nasopharyngeal cancer.
About 50% of the new cases of nasopharyngeal cancer are far higher than the global average, especially in certain regions of China such as Guangdong.
The incidence rate is 20-40 cases per 100,000 people
.
In particular, it should be noted that the treatment options for recurrent/metastatic nasopharyngeal carcinoma are limited.

The major breakthrough in nasopharyngeal carcinoma by teriprizumab is the most noteworthy development of Chinese local varieties.
Therefore, the progress of tereprizumab in this indication has attracted global attention, and the FDA has granted this variety breakthrough twice.
Sex therapy qualifications
.
Especially the JUPITER-02 study, which also shines in ASCO in 2021, is the first-line treatment of advanced nasopharyngeal carcinoma.

The JUPITER-02 study has now been published in Nature Medicine

Source: 2021 ASCO Junshi Bio

Expand overseas opportunities: Cinda-Eli Lilly, BeiGene and Novartis join hands to expand overseas rights

Typical cases of PD(L)1 going to sea

From the above, we can clearly see that on the PD(L)1 track, “severe gatherings, weak differentiated competition, and small market space”, in the first echelon, the two transactions made by Cinda and BeiGene are in the industry.
It is widely known that these two transactions are milestones.
It is certain that the advantageous resources of Eli Lilly and Novartis will greatly accelerate the internationalization of these two varieties
.

Leveraging on sales channels, many domestic companies have joined the marketing giants

In the domestic PD(L)1 track, most companies are emerging Biotech, such as BeiGene, CStone Pharmaceuticals, Kangfang Biotech, etc.
Most of these companies do not have mature sales teams, so many companies choose traditional companies or MNC companies to build Sales channels accelerate the market penetration of varieties
.
Here are a few very classic examples-

These three transactions also have important value on the PD(L)1 track.
We all know that it is very challenging for a company to have basic research, translational research, drug discovery, clinical development, and commercialization capabilities at the same time
.
In order to accelerate the commercialization of varieties and gain market competitive advantages, Chinese PD(L)1 R&D companies have explored several classic models:

1.
Bundle domestic traditional companies, such as Envolimab developed by Corning Jereh.
In March 2020, Corning Jereh signed an agreement with Simcere Pharmaceuticals.
In the agreement, Corning Jereh will be responsible for the production and supply of drugs.
Simcere Pharmaceuticals is responsible for the sales of cancer indications in mainland China;

2.
Bundled with MNC companies, such as CStone Pharmaceuticals and Junshi Biology.
The two companies have successively reached cooperation with MNC companies.
In the domestic market, AstraZeneca and other multinational giants have been deeply involved in the domestic market for many years and have extensive channels, especially Aspen Likang has established a strong promotion capability in the county market
.

This article starts with the approval of the listing of Paimrizumab.
Under the circumstances of PD(L)1 "low-level repeated competition and increasingly compressed market space", it introduces the domestic PD(L)1 track companies’ In the current competition situation, each company is actively consolidating its competitive position in the Chinese market; actively deploying high-burden tumors in China; actively cooperating with companies with strong marketing capabilities to make up for the lack of commercialization; at the same time, actively seeking overseas partners to explore overseas markets Opportunity
.
It is believed that within this year, the Chinese PD(L)1 variety will be approved in the US market