In-depth inventory: What trends do the FDA's approval of 53 innovative drugs this year represent...

As of the time of writing, the FDA's Center for Drug Evaluation and Research (CDER) had approved 53 innovative drugs as of the end of 2020.
2020, when the new crown outbreak becomes a global focus, the FDA's efforts to approve innovative new crown therapies, tests and vaccines are likely to be of greater concern.
, as of December 22, the FDA had issued emergency use authorizations (EUA) for 306 COVID-19-related sampling and testing methods, and approved the first innovative drug to treat new coronavirus infections.
month, two new crown vaccines based on mRNA technology were also awarded EUA by the FDA, bringing hope for progress in controlling COVID-19.
the timely completion of routine reviews of innovative drugs is one of the industry's concerns, even as the review work related to the new crown outbreak takes up a lot of FDA time and effort.
as of the time of writing, the FDA gave a satisfactory answer in reviewing the launch of innovative drugs.
, the number of innovative drugs approved by CDER this year lags only behind the record 2018 (59) and ranks second on record.
Photo Source: Pharmaceutical Mingkangde Content Team Charting: As of December 25, 2020, the proportion of orphan drugs approved by the FDA has gradually increased in the number of approved innovative therapies, reaching a 10-year high.
, 32 innovative therapies have been approved this year, accounting for 60.4 per cent of new drugs approved throughout the year.
a 10-year high in proportion, higher than its 2018 peak (57.6 per cent).
The number and proportion of orphan drugs approved from 2010 to 2020 (as of December 25, 2020, data source: FDA official website, Pharmacy Mingkangde Content Team Drawing) The development of orphan drugs for rare diseases not only benefited from the incentives of various regulatory measures issued by the FDA, but also reflected the importance that the pharmaceutical industry attaches to the development of rare disease therapies.
of the orphan drugs approved this year are for rare diseases with a small number of patients.
e.g. the first drug treatment for neurofibromatosis type 1, Selumetinib, the oligonucleotide therapy viltolarsen for Duchy muscular dystrophy (DMD), the first oral innovation for spinal muscular dystrophy, etc.
, on the other hand, with a better understanding of the molecular biology of cancer, researchers are able to develop targeted and precise therapies based on specific mutations carried by tumors.
the number of patients treated by segmenting them according to molecular biological characteristics also met the criteria for eligibility for orphan drugs, which also increased the number of orphan drug approvals.
this year, the FDA approved a number of cancer drugs specific to specific molecular biological characteristics, including Avakit (avapritinib) and RET inhibitors Gavareto (pralsetinib), Novarma's MET inhibitor Tabrecta (capmatinib), Lilly's Loxo Oncology, and others.
these precise treatments for specific gene variants tend to reduce adverse drug reactions while getting better results.
the rise of innovative treatment models, in addition to traditional small molecule drugs and monoclonal antibody therapies, this year the FDA approved several new treatments with innovative treatment models.
Lumasiran, developed by Allenlam Pharmaceuticals, became the third RNAi therapy approved by the FDA in three years.
car-T therapy Tecartus, developed by Kite Pharma, a subsidiary of Gilead Sciences, also became the third CAR-T therapy approved by the FDA.
Photo Source: Pharmaceutical Mingkang content team drawing, as of December 25, 2020 Review 2020, the FDA has approved a total of six drugs with new treatment models (defined as antibody-coupled drugs, gene therapy, cell therapy, and oligonucleotide therapy), almost the same number as in 2019 (7).
the FDA remains on the right to approve innovative model drugs, given that the new crown outbreak may have affected Novardo's RNAi therapy inclisiran and Centra's CAR-T therapy liso-cel, which were approved this year.
number of approved therapies with innovative treatment models also reflects the importance that the biopharmaceutical industry attaches to these treatment models.
the next generation of biotherapeutics (next generation Biotherapeutics, NGB), represented by cell therapy, gene therapy and oligonucleotides, has grown rapidly over the past five years, according to IQVIA's 2019 Research and Development Achievements (2019 R and D Achievements) report.
2019, 99 in-process products entered the post-clinical research and development pipeline, increasing the number of products under development to 369, a threefold increase over 2014.
's next-generation biotherapy research and development pipeline (Photo source: Resources 2) and these NNGB therapies are more likely to be approved by the FDA without the need for Phase 3 clinical trials than other traditional in-study therapies.
because the FDA believes these in-study therapies are designed to treat patients with seriously unseeded medical needs.
means that while NNGB therapies have a smaller number of Phase 3 clinical trials, they may be closer to being approved for early benefit to patients than non-NNGB therapies.
In the area of antibody association drugs (ADCs), improvements in ADC construction techniques in recent years have effectively improved the drug's benefit/risk ratio, and significant advances have been made in the design of cytotoxic molecules and in the stability of the connecting sub-factors that connect antibodies and loads.
field has also become a hot topic in the development of innovative therapies in recent years.
ADC research and development pipeline statistics show that there are currently hundreds of ADC therapies in the clinical development stage, the treatment of about 400 kinds of adaptive diseases.
Compared to traditional small molecule and antibody therapies, these innovative treatment models offer the advantages of combining the benefits of traditional therapies (e.g., ADC can combine the specificity of antibody therapy with the lethal effects of chemotherapy drugs), can target targets where traditional therapies are difficult to target, and offer a cure that benefits for life.
, at this year's BIO 2020 conference, Dr. James Sabry, Roche's global head of pharmaceutical collaboration, said that in 30 years' time, cell and gene therapy will be the mainstream of future therapies! We look forward to the new year, more new drugs can be approved at an early time, change the lives of the vast number of patients.
References: s1. Novel Drug Approvals for 2020. Retrieved December 25, 2020, from 2019 R&D Achievements. Retrieved June 9, 2020, from