Looking ahead to 2021, these important events in the field of medical health care are of great concern

2021 has arrived.
is certain that the development of new crown vaccines and therapies will remain one of the main concerns in 2021.
in the field of health care that deserve attention in addition to the research and development activities related to the new crown outbreak? Today's Drug Mingkang content team will combine public information to list events of concern in 2021.
the development of new crown vaccines and therapies effectively curb the development of the epidemic?By the end of 2020, several new crown vaccines have been approved in many countries and regions around the world, including the inactivated virus vaccine of the National Pharmaceutical Group; Pfizer/BioNTech; and the mRNA new crown vaccine developed by Modelna; AstraZeneca/Oxford University; and the adenovirus new crown vaccine developed in Russia.
the advent of these vaccines offer hope for controlling the new crown outbreak.
addition to these new crown vaccines, more than 50 new crown vaccines have been developed in the pipeline and are already in clinical development.
Among the notable vaccines in the study are the recombinant new crown vaccine based on the Ad5 adenovirus vector developed by Janssen, a subsidiary of Johnson and Johnson, and concino Bio and Concino Bio/Chen Wei, a member of the Chinese Academy of Engineering.
both vaccines use adenovirus vectors that cannot be replicated to express the prickly protein of the new coronavirus.
they are unique in that they are designed to provide effective protection through one vaccination.
both vaccines are already in Phase 3 clinical trials.
2020, Johnson and Johnson announced that phase 3 clinical trial ENSEMBLE had been fully registered with approximately 45,000 participants.
expects the interim results of clinical trials to be available by the end of January, and if data show the vaccine is safe and effective, the company plans to file an emergency use authorization (EUA) application with the FDA in February and regulatory filings in other parts of the world.
In the development of antiviral therapies, Redsyvir, developed by Gilead Sciences, and medium and antibody therapies developed by Lilly and Regeneron have been officially approved by the FDA or treated by EUA for COVID-19 patients.
these therapies need to be given infusions in hospital settings, limiting their use to some extent.
oral antiviral drugs have shown remarkable results in treating HIV infection and HCV infection, and in the new year, oral antiviral therapy for new coronavirus may provide a powerful treatment option for COVID-19 patients.
in the development of oral antiviral therapies, the AT-527, developed jointly by Roche and Atea Pharmaceuticals, and the MK-4482 (EIDD-2801) jointly developed by Mercedon andback Ridge Biotherapeutics, are of concern.
both of these small molecular inhibitors in the study of antiviral therapies are oral RNA-dependent RNA polymerases.
AT-527 is currently being tested in Phase 2 clinical trials and MK-4482 is used in Phase 2/3 clinical trials to treat hospitalized COVID-19 patients.
they may be used not only as oral therapy to treat inpatients, but also as potential for treating non-hospitalized patients, as well as an option for post-exposure prophylactic treatment.
AT-527 (left, Picture Source: References) and MK-4482 (right, Picture: Julius Senegal, Public Domain, via Wikimedia Commons) are expected to be approved for multiple CAR-T therapies and oligonucleotide therapies in 2021, and the FDA is expected to approve three CAR-T therapies to double the number of approved CAR-T therapies.
, the CAR-T therapy lisocabtagene maraleucel (liso-cel), which targets CD19 antigens, is being reviewed by the FDA for the treatment of adult patients with relapsed/refractic (R/R) large B-cell lymphoma (LBCL).
addition, two CAR-T therapies targeting B-cell mature antigens (BCMA) are expected to be approved for the treatment of recurring/refractic multiple myeloma.
, the idecabtagene vicleucel (ide-cel), developed jointly by BMS and Bluebird bio, has been granted priority review by the FDA.
car-T therapy, cilta-cel, developed jointly by Jansen and Legendary Bio, also launched a rolling bioprotect product licensing application (BLA) late last year.
: 123RF Inclisiran is expected to be approved by the FDA this year for oligonucleotide therapy.
RNAi therapy, which targets mRNA that expresses the PCSK9 protein, effectively controls patients' "bad" cholesterol levels with just two stitches a year.
Sarepta Therapeutics' phosphate diamide (PMO) casimersen has been awarded FDA priority review for the treatment of specific patients with ducty muscular dystrophy (DMD).
can the treatment of Alzheimer's disease be approved by the FDA?The amyloid antibody aducanumab, developed jointly by Biogen and Eisai, has been granted priority review by the FDA and is expected to receive a response around March.
Alzheimer's disease (AD) is the most common neurodegenerative disease among the elderly, with more than 35 million patients worldwide in 2019.
and since 2003, the FDA has not approved any new drugs to treat AD, and several targeted amyloid therapies have failed to achieve significant results in Phase 3 clinical trials.
, the potential approval of aducanumab not only represents hope of slowing the progression of the disease in a wide range of AD patients, but may also bring a new lease of life to the amyloid hypothesis.
in two Phase 3 clinical trials, the performance of aducanumab was inconsistent, and in a clinical trial called EMERGE, aducanumab reached the main endpoint of the trial, but in a clinical trial called ENGAGE, aducanumab did not show significant efficacy.
analysis of the trial data by scientists at Yanjian found that some patients treated with high doses of aducanumab in the ENGAGE trial showed similar efficacy to those in the EMERGE trial.
: Alzheimer's disease new drug is back to life! Why is it going to have a "stunning reversal"?The FDA will weigh the huge unseeded medical needs of AD patients and make a final decision on the overall evaluation of the Aducanumab clinical trial program.
's first KRAS inhibitor is expected to be approved as the most commonly mutated cancer-causing gene in human cancer, however, since the kras protein surface does not have a pocket suitable for small molecule inhibitor binding, the development of small molecule drugs targeting KRAS has not made a major breakthrough in 40 years.
recent years, basic scientific research has found that there is an isomer point in kraS G12C mutants that can be combined with co-price inhibitors.
by binding to the mutant cysteine, KRAS G12C inhibitors are able to lock kraS's image inactive, thereby inhibiting the activity of kras G12C mutants.
breakthrough has led to the development of KRAS G12C co-price inhibitors by a number of biotechnology and pharmaceutical companies.
this year, research and development efforts in this area are expected to pay off, and Amgen late last year submitted a new drug application to the FDA for the KRAS G12C inhibitor sotorasib, which treats patients with the kras G12C gene mutation, for treatment of non-small cell lung cancer (NSCLC).
is expected to be approved this year.
KraS G12C inhibitor regimen (Photo: Mirati Therapeutics website) In addition to Amjin, KRAAS G12C inhibitor adagrasib, developed by Mirati Therapeutics, also showed a 45% confirmed objective mitigation rate and a 96% disease control rate in clinical trials for patients treating advanced NSCLC, and is expected to file a new drug application in the second half of this year.
pharmaceutical companies such as Mercer Sandon, Roche, Novarma and Grigg Ingham are also developing KRAS inhibitor monodrugs or combination therapies.
that the approval of the first KRAS inhibitor is only the beginning of a boom in KRAS targeted therapies.
continue to receive capital support in the area of health care?In 2020, the development of biomedicine is one of the keys to leading people around the world out of the new crown pandemic.
capital boost to health care is also at an all-time high.
Silicon Valley Bank's investment and financing report, released in the third quarter of this year, predicts that global investment in healthcare could reach $52.5bn in 2020, up from $38.5bn in 2019.
addition to biomedicine, investment in medical devices and diagnostics has also increased significantly.
impact of the new crown pandemic is the urgency of the need for health technology.
in virtual clinical trials, remote patient monitoring, and telemedicme has increased significantly.
are expected to grow further in 2021, when the new crown outbreak is not yet under control.
industry analysts said the new crown outbreak has raised awareness of the need to improve health through medical innovation.
this need will continue to support continued capital investment in health care.