As the COVID-19 epidemic continues and sporadic outbreaks occur in many countries and places at home and abroad; Innovative drug development never stops!
Fast forward to the final quarter of 2022. According to incomplete statistics of public information, 15 new drugs will be the first batch of FDA marketing in the fourth quarter of 2022, including 5 monoclonal antibodies, 4 chemotherapies, 2 dual antibodies, 1 ADC therapy, 1 gene therapy, 1 microbiological therapy and 1 combination therapy. The indications involve many therapeutic fields, such as tumor field, rare disease and common chronic disease.
Astrazeneca's tremelimumab, MiratiTherapeutics' adagrasib and SpectrumPharmaceuticals' poziotinib are expected to break the market dominance of previously marketed drugs in terms of targets and drug types, respectively. Share the corresponding treatment area of the market cake.
Astrazeneca's tremelimumab is expected to become the second CTLA-4 antibody to be approved globally, after Yervoy (BMS). tremelimumab, after 18 years in development, has had many twists and turns in its fortunes; After going through Pfizer and Astrazeneca, he tried several indications for different cancer types, and finally came to the dawn of victory.
Yervoy has been one of the world's best-selling anti-tumor drugs since it was approved by the FDA, with sales of $2.02 billion in 2021, up 20% year over year. But tremelimumab's approval could add to the sluggish growth of Yervoy in recent years, which has been fueled by a growing number of antibody drugs.
MiratiTherapeutics' adagrasib is expected to become the second KRASG12C inhibitor approved after Sotorasib (Amgen). As we all know, KRAS was once considered as an "undrugable" target. Currently, only Amgen's Sotorasib has been marketed globally, and the market time is less than one year. If Miratitics' adagrasib is approved by December 14, 2022, it will directly challenge Sotorasib, and it remains to be seen who will succeed in the KRASG12C inhibitor market.
At present, the global distribution of KRAS target research enterprises include Jinfang Pharmaceutical, Bayda Pharmaceutical, Maya Li Pharmaceutical, Amgen, Yifang Biological, MiratiTherapeutics, Jansen, Genex, Novartis, Boehringer Ingelheim, Eli Lilly and other enterprises.
poziotinib is expected to be the second HER2-mutated NSCLC drug approved after T-DXd (Daiichi Sankyo). On August 11, the FDA approved Enhertu as a second-line treatment for HER2-mutated non-small cell lung cancer, becoming the world's first drug approved for HER2-mutated NSCLC. The current challenge and future development direction of targeted therapy for HER2 gene variant NSCLC. poziotinib, if approved, will be a major breakthrough in anti-NSCLC treatment.
However, it is worrisome that the release of many drugs, which were supposed to be approved early this year, has been delayed due to the COVID-19 pandemic and other factors. It is expected that they will be approved in the fourth quarter as scheduled.
Tririplimumab, a PD-1 mab, was submitted to the FDA on a rolling basis as early as March 2021 for BLA for the treatment of recurrent or metastatic nasopharyngeal carcinoma. However, COVID-19 related travel restrictions prevented the FDA from completing the necessary field verification. On July 6 of this year, Junshibio resubmitted its biologics License application (BLA) to the FDA for the use of tririplimumab plus gemcitabine/cisplatin as first-line therapy for patients with advanced recurrent or metastatic nasopharyngeal carcinoma (NPC) and as a single agent for second-line or higher treatment after platinum-based therapy for patients with recurrent or metastatic nasopharyngeal carcinoma (NPC). The PDUFA is set for December 23, 2022.
In fact, tririplizumab injection is the first domestic PD-1 targeted mab approved for marketing in China. It has been approved for 5 indications in China; In December 2020, tririplimumab passed the national medical insurance negotiation for the first time. At present, three indications have been included in the 2021 Drug List, which is the only anti-PD-1 mab used in the treatment of melanoma and nasopharyngeal carcinoma in the national Medical insurance List. If successfully approved, it is also a symbol of the success of domestic biosimilar drugs to the sea.
AT-GAA is a two-component therapy consisting of cipaglucosidasealfa and megalstat. In preclinical studies, AT-GAA has been associated with increased levels of the mature lysosomal form of GAA and decreased glycogen levels in muscle, remission of autophagy defects, and improved muscle strength. In May of this year, the Company announced that the FDA extended the PDUFA date for the AT-GAA to 2022.
ublituximab is a novel glycoengineered anti-CD20 monoclonal antibody targeting a unique epitope of the CD20 antigen on mature B lymphocytes that is distinct from the approved CD20 monoclonal antibody. Including ofatumumab, ocrelizumab/rituximab, obinutuzumab (GA101). ublituximab is known to be more effective than the blockbuster multiple sclerosis drug Aubagio (teriflunomide) in relapsing multiple sclerosis (RMS). On May 31, TGTherapeutics announced that the FDA extended the PDUFA date for the BLA of ublituximab therapy complex RMS to December 28, 2022.
teplizumab is an anti-CD3 monoclonal antibody designed to prevent or delay T1D in individuals at high risk of having two or more autoantibodies associated with type 1 diabetes. On June 30, ProventionBio announced that the FDA has extended the PDUFA for teplizumab to November 17, 2022.
