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At the forefront of new drugs, looking back at the biopharmaceutical industry in 2021, there are many hot spots that have attracted attention
.
Looking ahead to 2022, these hotspots will continue or usher in key nodes
01.
Tigit: 20 years of hard work will usher in gains
Tigit: 20 years of hard work will usher in gains
[Review] Genentech, a Roche subsidiary, discovered and verified Tigit in 2002, and is currently a leader in research on this target
.
Tiragolumab's impressive Phase 2 clinical trial data is the envy of its peers
【review】
[Prospect] Roche Tiragolumab's late research data will be announced, and the industry and competitors will pay special attention
.
At the same time, whether Tigit targets small followers will become the next target of the giant's transaction, which is also worthy of attention
【Outlook】
02.
KRAS: Make persistent efforts after the breakthrough
KRAS: Make persistent efforts after the breakthrough
[Review] In the KRAS target competition, Amgen Lumakras (sotorasib) took the lead in crossing the finish line in May 2021 and is currently in the leading position
.
After decades of failure, KRAS eventually became a "drugable" target
【review】
[Prospect] As a competitor of Amgen, Mirati has experienced an ups and downs journey, and adagrasib will break through in 2022
.
Amgen's sotorasib is undergoing a dose optimization study.
【Outlook】
03.
Protein degradation agent: the terminator of the "unable to drug" target
Protein degradation agent: the terminator of the "unable to drug" target
【Review】 Because of the potential advantages in adverse reactions, drug resistance and regulation of "non-drugable" targets, targeted protein degradation agents represent a new treatment method
.
At present, 15 targeted degradation agents (from heterologous bifunctional protein cleavage targeted chimera (PROTAC) to molecular glue) have entered the early stage of clinical trials
【review】
[Prospect] The technology continues to mature, and the current biopharmaceutical industry is increasingly interested in protein degradants
.
In 2022, with the deepening of clinical trials of protein degrading agents, it may become a new territory for large pharmaceutical companies to compete for
【Outlook】
04.
Gene therapy: running wild under safety issues
Gene therapy: running wild under safety issues
[Review] Although these gene therapies are promising, the FDA has raised safety issues ranging from liver toxicity to kidney damage to neuronal loss
.
As gene therapy enters the market and patients die frequently in early clinical trials, these problems have long been noticed by regulatory agencies
【review】
[Prospect] However, this has not stopped the enthusiasm for gene therapy
.
The analysis of gene therapies in current clinical trials reveals the depth and breadth of the R&D pipeline, ranging from a large number of extremely rare diseases, such as GM1 gangliosidosis and Sanfilippo syndrome type A, to more common diseases, including Parkinson’s disease And wet AMD
.
Lysosomal storage disease is an important area of concern
.
Ophthalmic diseases and neurological diseases are the most interesting areas for manufacturers
.
05.
Car-T: The track starts to be crowded
Car-T: The track starts to be crowded
[Review] Fosun Kate's CAR-T cell therapy Akilunza injection and WuXi's Noreki Orenza injection have been approved for marketing in China
.
CAR-T cell therapy has officially opened a new era in China
.
CAR-T cell therapy is also considered to be a crowded area after PD-(L)1
.
[Prospect] In the fierce competition of CAR-T cell therapy, there has also been a serious problem of target homogeneity
.
For example, the research on CAR-T cell therapy for the popular CD19 target has a relatively small patient base and a limited therapeutic market
.
It will undoubtedly be very difficult for companies to enter the market in the future .
In addition, the high pricing of such products has been controversial
.
How to convert high-tech products into high market value still has a long way to go for domestic enterprises
.
06, Tyk2: Open the post-Jak era
06, Tyk2: Open the post-Jak era [Review] As Jak inhibitors have repeatedly reported safety issues, regulatory agencies have become more cautious about the extension of indications for these drugs and the review of new drug applications: new black boxes, delayed review and approval have become the norm
.
[Prospect] Bristol-Myers Squibb Tyk2 inhibitor deucravacitinib entered the market application in the United States and Europe at the same time.
It is expected to be approved in the third and fourth quarters, and is expected to become the first approved Tyk2 inhibitor
.
As a member of the Jak family, whether Tyk2 will repeat the safety of Jak inhibitors is worth looking forward to
.
07.
RSV: A new battlefield for vaccines
RSV: A new battlefield for vaccines
[Review] The new crown vaccine has brought substantial benefits to pharmaceutical giants such as Pfizer, and is expected to make Pfizer's revenue reach a peak of US$101.
3 billion in 2022
.
[Prospect] The next new vaccine battlefield will be the field of respiratory syncytial virus (RSV) vaccines involving GlaxoSmithKline, Pfizer and Johnson & Johnson
.
2022 should be an important year for the release of the results of late-stage clinical trials
.
At the same time, Moderna and Sanofi are also chasers in this field
.
08.
PD-(L)1: Domestic drugs usher in a critical year for the overseas market
PD-(L)1: Domestic drugs usher in a critical year for the overseas market
[Review] In the crowded PD-(L)1 market at home and abroad, latecomers have no way out
.
The fierce price war has made many domestically-made PD-(L)1s go overseas through cooperation
.
The world's first subcutaneous PD-L1 inhibitor Envolimab injection is on the market, looking for opportunities for "dislocation competition"
.
[Prospect] Whether the many domestically produced PD-(L)1 accepted by the FDA can be successfully approved will become the cornerstone for testing the quality of its products and clinical trial data, and it will also open up a fan for the current domestic research on biological drugs to enter the international market Window
.
At the same time, Envolimab injection will also become a verifier of whether the convenience of subcutaneous delivery can promote sales
.
09.
AD: A new dawn for major pharmaceutical companies?
AD: A new dawn for major pharmaceutical companies?
[Review] Biogen/Eisai's Alzheimer's disease (AD) drug Aduhelm (aducanumab) was approved as one of the biggest regulatory milestones and controversies in 2021
.
[Prospect] The approval of Aduhelm has strengthened the determination of other developers with similar drugs, and they have promoted their respective drug application approval plans.
The data that is vital to these projects will also be announced in 2022
.
Eli Lilly’s donanemab and Bojian/Eisai’s lecanemab have submitted a rolling biologics license application (BLA) to the FDA, and Roche’s gantenerumab is also undergoing phase 3 trials
.
Whether these drugs can be approved has become a hot potato for testing regulatory agencies
.
10.
Transaction: high cost and hard desire to suppress
Transaction: high cost and hard desire to suppress
[Review] The research and development of new drugs in the biopharmaceutical field is inseparable from capital investment.
However, the intervention of capital has triggered increasing transaction costs for mergers and acquisitions and project licensing in the biopharmaceutical industry
.
Nowadays, early-stage projects often require tens of millions of dollars in advance payments, and cancer project advances have reached an average of 120 million US dollars, and licensing transactions for new drug projects increasingly require "capital"
.
[Outlook] Although M&A activities in the biopharmaceutical industry will be slightly calmer in 2021
.
However, judging from the large transactions in the last month, the enthusiasm for mergers and acquisitions by pharmaceutical companies seems to be rekindled
.
With the divestiture of non-core assets of large pharmaceutical companies, ample cash for vaccines, and a growing desire for innovation, it is expected that the enthusiasm for M&A transactions in 2022 will rebound
.
