Since the approval of the US FDA has been blocked, pessimism in the innovative drug market has spread again

Since the approval of the US FDA has been blocked, pessimism in the innovative drug market has spread again, but this has not lasted long

3.
The FDA believes that the biodiversity of Innovent Biologics single Chinese patients cannot be confirmed; Legendary Biologics takes a multicenter clinical approach (US, Japan, EU, etc.

).

Based on this, before the approval, everyone's expectations for Cilta-cel have been high
.

Of course, Cilta-cel's strength lies in excellent clinical data
.

In the key CARTITUDE-1 study, 97 patients with R/R MM experienced early, deep, long-lasting remission with a total response rate (ORR) of 98% (95% CI: 92.
7–99.
7) and a strict complete response (sCR, 95% CI: 68.
8–86.
1)
in 78% of patients.
At a median follow-up time of 18 months, the median duration of response (DOR) was 21.
8 months (95% CI, 21.
8-unpredictable).

This proves that Cilta-CEL is a BIC product
targeting BCMA for multiple myeloma.

List of CAR-T therapies available worldwide

Data sources: pharmaceutical intelligence data, corporate announcements, etc

FIC/BIC sea acceleration

Why do innovative drugs have to go to sea? Of course, it is to pursue the maximization of
the innovative market.

Faced with the pressure on drug prices brought about by the domestic collection policy and the national medical insurance negotiations, everyone began to realize that it is difficult to have more than $1 billion of blockbuster drugs
in the domestic market.
Pharmaceutical companies limited to the domestic market will face the dilemma that R&D investment cannot be recovered
.
Under this trend, taking the international route and participating in global competition will be an inevitable choice
for Chinese pharmaceutical companies in the future.

It is reported that as early as 2009, the clinical study of repagliptin phosphate of Hengrui Pharmaceutical was double-reported in China and the United States and approved by the United
States.

However, it was not until 2017, after China officially joined the International Council for the Coordination of Registration Technology for Human Use (ICH), that the Sino-US double reporting and synchronous development of innovative drugs by local pharmaceutical companies became the mainstream
.
After 2017, the number of clinical approvals in the Sino-US double report increased by nearly 10 times
compared with that before 2017.

In 2019, zebutinib became the first local anti-cancer drug
approved in China in the United States.

Zebutinib conducted global multicenter, head-to-head trials: the ALPINE study and the SEQUOIA study, challenging the clinically dominant ibrutinib and benzamustine plus rituximab (B+R treatment regimen) to successfully demonstrate its best-in-class potential
.

BeiGene's efforts were quickly rewarded
.
In 2021, Zebutinib generated global sales of approximately RMB1.
4 billion, an increase of 423%
year-on-year.
Full-year sales in the U.
S.
were $115.
7 million, up 535%
year-over-year.
Moreover, zebutinib has added two new indications in the United States in 2021, and it is expected to add two more indications by the end of this year, with great
growth potential.

In February 2022, the legendary BCMA CAR-T therapy Cedakhiolense was approved by the US FDA for marketing, becoming a new milestone
.
Cilta-cel is priced at $465,000 and its main competitor, Bristol-Myers Squibb's Abecma, is priced at $419,500
.
Johnson & Johnson had estimated that Cilta-cel was expected to reach a peak sales volume of $5 billion
.

At the 40th J.
P.
Morgan Healthcare Annual Conference held in January 2022, more than 40 domestic pharmaceutical companies participated, including innovative pharmaceutical companies such as BeiGene, Cinda Biologics, Junshi Biologics, Cornerstone Pharmaceuticals, Rongchang Biologics, Kangfang Biologics, and Tianjing Biologics, as well as veteran pharmaceutical companies such as Hengrui Pharmaceutical
.
We can see that more and more local pharmaceutical companies are beginning to participate in international competition and look for opportunities to
go global.

epilogue

From zebutinib to Cilta-cel's successful departure to sea, it tells us that innovative drugs with clinical value are what the market expects, and that the pile of me too will not work
.
Innovative drugs go to sea, or like BeiGene, dare to carry out "head-to-head" research to prove their BIC attributes; Or like a legendary creature, at the beginning of the project, it has a unique path, positioning the research and development direction to solve the unmet clinical needs and select new targets for research
.

It is hoped that more FIC and BIC can be incubated in China in the future to benefit patients
.