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preface
prefaceIn 3 days, 2022 will be a complete page
of history.
This year, we witnessed division and union, and felt the cool and hot
of the world.
This year, Vientiane has been updated, and the environment for both internal research and development and external investment and financing has changed significantly
.
All the news this year has become a historical record: just yesterday, Drug Times released the "Top Ten Keywords" of the 2022 Pharmaceutical Circle, reviewing the bits and pieces of 2022 together and looking forward to the future
in 2023.
Today, we take stock of several blockbuster innovative drugs approved by the FDA in 2022, all of which have outstanding performance in a certain field: either "groundbreaking" or have characteristics
that other products cannot match.
Don't want to see all the Chang'an flowers in one day, just want to get a glimpse and know the whole leopard, and review the new drug launch process
in 2022 together.
Due to insufficient ability and limited level, if there are mistakes and omissions, welcome friends to criticize and correct in the comment area!
The first TCR dual antibody therapy was launched, setting a number of firsts
On January 26, 2022, the world's first TCR dual antibody therapy was approved
.
From Immunocore's Tebentafusp (trade name Kimmtrak), Kimmtrak has set several firsts: it is both the first TCR therapy approved by the FDA; It is also the first therapy to treat unresectable or metastatic uveal melanoma; It is also the first FDA-approved bispecific T cell linker
for the treatment of solid tumors.
Since then, the door to conquering solid tumors through cell therapy has been overcome, and TCR therapy will continue to shine in the future
.
.
Kimmtrak set several firsts
According to Immunocore's financial data, Kimmtrak's total sales revenue in the first three quarters of this year has reached 74.
5 million pounds.
Domestic CAR-T successfully broke through, legendary creatures create legends!
On February 28, 2022, the first fully domestic CAR-T cell therapy was approved by the FDA! The domestic CAR-T cell therapy of CARVYKTI (Cedaki Celcel) developed by Nanjing Legend Biotechnology was approved by the FDA for the treatment of relapsed and refractory multiple myeloma
.
There is no doubt that the successful overseas expansion of legendary biology has greatly boosted the morale of Chinese pharmaceutical companies, and sweeping away the haze after the failure of Cinda's PD-1 on February 11 is a milestone for China's innovative drugs
.
At present, a number of domestic CAR-T products are striving for approval for marketing, and the blowout is obvious
.
.
Approval of two brand new therapies in one day, what happened on March 18
On March 18, the FDA approved Bristol-Myers Squibb's "first-in-class" therapy Opdualag.
The therapy consists of the anti-LAG-3 antibody drug relatlimab in combination with the anti-PD-1 antibody Opdivo (nivolumab) for the treatment of advanced melanoma
in patients older than 12 years.
It is worth mentioning that relatlimab is the first LAG-3 antibody approved by the US FDA, and it is also the first innovative cancer immunotherapy
approved for new immune checkpoints in the past 10 years.
On the same day, Marinus
Pharmaceuticals Inc.
announced that the FDA has approved Ztalmy (trade name
ganaxolone) oral suspension marketed for the treatment of seizures
associated with cyclin-dependent kinase-like 5 (CDD) deficiency (CDD) in patients older than two years.
This is the first FDA-approved therapy
for this patient population.
approved for a new immune checkpoint in nearly 10 years.
This is the first FDA-approved therapy
for this patient population.
China's new drugs break the 25-year deadlock in the field of psoriasis, and this time the Chinese mainland approval is ahead!
In May 2022, the FDA approved the marketing of benvimod cream, developed by a subsidiary of Guanhao Biotechnology, which can be used to treat psoriasis, and is the only steroid-free topical drug approved for this type of disease in 25 years, providing an effective and low-side effect new option
for hundreds of millions of patients around the world suffering from psoriasis.
At the same time, the drug has successfully passed the "head-to-head" trial with the existing gold standard drugs for the treatment of psoriasis, and the clinical advantages are significant
.
It is worth mentioning that this innovative therapy was first approved for marketing
in Chinese mainland through the NMPA priority review process as early as 2019 with the support of the national major science and technology special project of "major new drug creation".
This is also the only innovative drug
approved by the FDA after the NMPA is approved for marketing so far.
in Chinese mainland through the NMPA priority review process as early as 2019 with the support of the national major science and technology special project of "major new drug creation".
This is also the only innovative drug
approved by the FDA after the NMPA is approved for marketing so far.
"The world's most expensive drug" appeared, and appeared, and appeared? The title changed hands three times.
.
.
On August 17, 2022, the FDA approved Bluebird Biotech's Zynteglo as the first gene therapy for the treatment of β-thalassemia, which has been awarded the title of "World's Most Expensive Drug" for a sky-high price of $2.
8 million per injection
.
Unexpectedly, just a month later, on September 16, Bluebird Biologics once again announced that its other gene therapy drug, Skysona, had been accelerated by the FDA for the use of alleviating early active adrenal leukodystrophy
between the ages of 4 and 17.
The treatment is priced at a whopping $3 million!
8 million per injection
.
Bluebird Biologics once again announced that its other gene therapy drug, Skysona, has received accelerated FDA approval for the use of early active adrenoleukodystrophy
in the ages of 4-17.
The treatment is priced at a whopping $3 million!
But what is even more unexpected is that only 65 days later, the world's most expensive drug has changed hands again! Hemgenix gene therapy, developed by Dutch biotech company UniQure, has skyrocketed that figure to $3.
5 million a shot! This drug is used to treat hemophilia B, and only one injection can greatly relieve hemophilia symptoms
in the long term.
5 million a shot!
There is no most expensive, only more expensive, will the title of "the world's most expensive drug" change hands again in 2023, let's wait and see
.
Is there also a cure for type 1 diabetes? Although it is only delayed, it is also promising
On November 17, the FDA announced approval of Provention
Bio's CD3 monoclonal antibody teplizumab is available for the purpose of delaying the disease progression
of stage 3 diabetes mellitus in adults and stage 2 type 1 diabetes in children 8 years of age and older.
This is the only drug
to date that can delay the onset of type 1 diabetes.
of stage 3 diabetes mellitus in adults and stage 2 type 1 diabetes in children 8 years of age and older.
This is the only drug
to date that can delay the onset of type 1 diabetes.
Teplizumab was terminated for a time when the Phase 3 trial did not meet its primary focus and was transferred to Provention
.
Teplizumab's road to market has been a twist and turn.
In 2010, a Phase 3 trial of the drug failed to meet its primary endpoint, and the trial was suspended before being sold to Provention
in 2018.
After the re-shaken teplizumab obtained FDA breakthrough therapy certification in 2019, and was rejected for marketing 21 years due to pharmacokinetic comparability issues, Provention resubmitted the BLA in January this year and finally successfully marketed
.
Although Teplizumab can only delay the course of the patient's disease and cannot completely cure type 1 diabetes, it still undoubtedly brings the dawn
of type 1 diabetes patients who are still in the early stages of the disease.
This drug also points out many new ideas
for the diabetes treatment problems that have plagued the academic community for a century.
"Fecal therapy" was finally approved, and microbial drugs were launched with high votes from the expert committee
On November 30, the FDA approved Rebyota, a microbiome-based live biotherapy developed by Rebiotix, the first fecal microbiota product approved by the FDA to prevent recurrence of infection in adults over the age of 18 with Clostridium difficile infection (CDI
).
。 I'm afraid this drug will be a little embarrassing for patients who need it: made from feces donated by qualified personnel, and then administered rectally.
.
.
Seriously, microbial therapy is a promising area in the future, especially in today's "one foot higher, magic one foot higher" in the current bacterial resistance, microbial therapy in reducing the recurrence rate of patients and solving antibiotic resistance has a prospect
that cannot be ignored.
).
Microbial therapy is a promising area in the future, especially in today's "one foot higher, one foot higher" in the current bacterial resistance, microbial therapy in reducing the recurrence rate of patients and solving antibiotic resistance has a prospect
that cannot be ignored.
epilogue
epilogueLooking back on 2022, it is time
for new drugs to take off.
During this year, we were overjoyed by the hundreds of Chinese pharmaceutical companies sailing overseas, and we were also stunned by the huge BD deals that were repeatedly refreshed; We ask, "Can the most expensive medicine be more expensive?" , also got the answer
of "zero breakthrough in the industry".
New drug news is happening all the time, and the epic of 2023 is about to be written
by Jun.
