New therapies approved by FDA this year: TCR double antibody, domestic CAR T...

In just three days, 2022 will be history. This year, we witnessed division and union, and felt the warmth of the world. This year, everything changed, both internal research and development and external investment and financing environment has obviously changed.

All the news of the year has become a historical record: Just yesterday, Pharmaceutical Times released the "Ten key words" in the pharmaceutical industry in 2022, to review the 2022 bit by bit and look forward to the future in 2023.

Today, we take a look at some of the biggest innovative drugs approved by the FDA in 2022, all of which stand out in one area: they are either "groundbreaking" or have features that no other product can match.

I don't want to see all Changan flowers in one day, but just a glimpse to know the whole leopard, and jointly review the process of launching new drugs in 2022.

Due to the lack of ability, the level is limited, if there are mistakes welcome friends comment area criticism and correction!

The debut of the first TCR dual antibody therapy set several firsts

On January 26, 2022, the world's first TCR dual antibody therapy was approved. From Immunocore's Tebentafusp (Immtrak), which achieved a number of firsts: it was the first TCR treatment approved by the FDA; It is also the first treatment for unresectable or metastatic uveal melanoma. It is also the first bi-specific T-cell connector to receive FDA approval for solid tumors. Since then, the door of curing solid tumors through cell therapy has been conquered, and TCR therapy will continue to shine in the future.

Total sales of Kimmtrak were £74.5m in the first three quarters of this year, according to Immunocore.

In the face of CAR T are helpless solid tumor, TCR-T said there is no pressure, a number of Chinese enterprises have been actively layout......

Domestic CAR-T success, legendary creatures create legend!

On February 28, 2022, the first fully domestic CAR T-cell therapy was approved by the FDA. CARVYKTI, a domestic CAR T-cell therapy developed by Nanjing Legend Bio, was approved by the FDA for the treatment of relapsed and refractory multiple myeloma.

There is no doubt that the success of Legendary Biology has boosted the morale of Chinese pharmaceutical companies. It is a milestone for China's innovative pharmaceutical industry after the failure of Cinda PD-1 on February 11. At present, a number of domestic CAR-T products are in the market for approval, blowout obvious.

Go to sea and win! Nanjing legend CAR-T approved by FDA, what is behind the "success password"?

Two new treatments approved in one day. What happened on March 18th

On March 18, the FDA approved Bristol-Myers Squibb's "first-in-class" treatment, Opdualag. The treatment consists of relatlimab, an anti-LAG-3 antibody, in combination with Opdivo (nivolumab), an anti-PD-1 antibody, for patients with advanced melanoma who are older than 12 years of age. It's worth noting that relatlimab is the first LAG-3 antibody approved by the FDA and the first innovative cancer immunotherapy approved for a new immune checkpoint in nearly 10 years.

On the same day, MarinusPharmaceuticals announced that the FDA has approved Ztalmy (trade name ganaxolone) oral suspension for the treatment of seizures associated with cyclin dependent kinase-like 5 (CDKL5) deficiency (CDD) in patients over two years of age. It is the first treatment for this patient population to win FDA approval.

Milestone! FDA approves World's First LAG-3 Antibody! It becomes the third immune checkpoint inhibitor after CTLA-4 and PD-1/PD-L1

A new Chinese drug breaks a 25-year deadlock in psoriasis, with mainland China taking the lead this time.

In May 2022, the FDA approved Benvimode Cream, developed by a subsidiary of Guanhaobiobio, for the treatment of psoriasis. This drug is the only steroid-free topical drug approved for this disease in 25 years, providing an effective and new option with low side effects for hundreds of millions of patients worldwide suffering from psoriasis. At the same time, the drug successfully passed the "head-to-head" trial with the existing gold standard drug for the treatment of psoriasis, showing significant clinical advantages.

It is worth mentioning that, with the support of the national science and technology major project "Major New Drug Creation", this innovative therapy was approved for market in the Chinese mainland as early as 2019 after the NMPA priority review procedure. It is also the only innovative drug to be approved by the FDA after the NMPA has been approved for marketing.

FDA approves Benvermod Revelation: What we really need is the courage to be first and the will quality of Tang Seng!

'World's Most expensive drug' comes on, on, on? The title has changed three times...

On August 17, 2022, the FDA approved Bluebird Bio's Zynteglo as the first gene therapy for beta-thalassemia, already the world's most expensive drug at a staggering $2.8 million a shot. Just over a month later, on September 16, Bluebird Bio announced that Skysona, another gene therapy drug, had received accelerated FDA approval to slow early active adrenoleukodystrophy in ages 4-17. The price tag is $3 million!

From 2.8 million to 3 million, the world's most expensive drug has been broken! In just 30 days!

But more surprisingly, just 65 days later, the world's most expensive drug has changed hands again. The Hemgenix gene therapy, developed by Dutch biotech company UniQure, has pushed that figure to $3.5 million a shot! The drug is used to treat hemophilia B, with a single injection providing long-term, significant relief from hemophilia.

Not the most expensive, only more expensive, 2023 "world's most expensive drug" will change hands again, let's wait and see.

Is there a Cure for Type 1 Diabetes? It's only a delay, but it's also promising

On November 17, the FDA announced approval of ProventionBio's teplizumab, a CD3 monoclonal antibody, for delaying the progression of stage 3 type 1 diabetes in adults and stage 2 Type 1 diabetes in children 8 years of age and older. It is the only drug so far that can delay the onset of type 1 diabetes.

Teplizumab was switched to Provention at one point after Phase 3 trials failed to meet the main focus. Teplizumab's road to market has been bumpy. The Phase 3 trial of the drug fell short of its primary endpoint in 2010 and was suspended before being resold to Provention in 2018. After teplizumab received breakthrough therapy approval from the FDA in 2019 and was rejected 21 years ago due to pharmacokinetic comparability issues, Provention resubmitted the BLA in January this year and finally went to market.

Although Teplizumab only delays the disease, not cures Type 1 diabetes, it offers hope for those with the disease in its early stages. The drug also points to many new ways of thinking about diabetes treatment, a problem that has plagued the world for centuries.

The world's first T1DM new drug approved! The company's share price has turned green, but the big question is: Where to find the patients?

"Fecal therapy" has finally been approved, with a panel of experts backing the launch of a microbiological drug

On November 30, the FDA approved Rebyota, a microbiotherapeutic in vivo developed by Rebiotix, the first FDA-approved faecal microbiota product for the prevention of recurrent clostridium difficile infection (CDI) in adults over 18 years of age. It's a somewhat embarrassing drug for patients who need it: it's made from feces donated by qualified people and administered rectum...

Seriously speaking, microbial therapy is a promising field for the future, especially in today's bacterial resistance "high, the magic is high", microbial therapy in reducing the recurrence rate of patients, to solve the direction of antibiotic resistance can not be ignored.

First 'Fecal treatment' Approved by FDA! One small step for Hui Ling, one giant leap for microbial therapy

conclusion

Looking back to 2022, the new drugs took off just in time.

In this year, we have been excited by the hundreds of Chinese pharmaceutical companies sailing to the sea, but also by the repeated refresh of the huge BD transaction stunned; We ask, "Can the most expensive drug be any more expensive?" ", also received the answer "industry zero breakthrough".

New drug news is happening all the time, and the epic of 2023 is about to be written by you.