2021 World'S Top 10 Most Anticipated New Drugs List

21 Lu Shan, senior researcher of new Institute of health

In 2020, the pace of new drug approval in the major markets of the world will not be stagnant because of the epidemic situation. On the contrary, heavy drugs will appear frequently. From the current application progress, 21 new health research institute predicts that the following 10 "key" drugs of market concern will be approved by major global regulators in 2021. Among them, aducanumab, the Alzheimer's drug in Biogen's hands, is the largest potential drug to be marketed in 2021, and whether FDA will approve the drug to market is one of the biggest events in the field of biopharmaceutical in 2021.

01 Aducanumab

R & D enterprise: Bojian Biogen / Eisai

Indication: Alzheimer's disease

Market forecast: sales in 2026 will be 4.8 billion US dollars

Antidote: FDA's approval of Biogen's aducanumab will be one of the biggest events in the global biopharmaceutical industry in 2021. The antibody drug for Alzheimer's is also a highly anticipated project on the market. At present, the medical advisory body forecasts sales of $4.8 billion by 2026, which also puts aducanumab ahead of other potential new drugs. To get the antibody to market in 2021, the FDA must deny objections from the Advisory Committee, which almost unanimously voted against approval. FDA usually supports the opinions of these groups, but the FDA's supporting documents and the results of the Advisory Committee's vote make the results difficult to estimate. Whether Biogen can "bring the dead back to life" in 2021 deserves our attention.

02 Efgartigimod

R & D enterprise: argenx

Indications: IgG mediated autoimmune diseases

Market forecast: global sales of US $2.5 billion in 2026

21 antidote: efgartigimod is an antibody fragment under development to reduce the antibody against pathogenic immunoglobulin G (IgG) and block the IgG cycle. Blocking FcRn can reduce the expression of IgG antibodies and treat autoimmune diseases known to be driven by pathogenic IgG antibodies, including myasthenia gravis (mg), a chronic disease that causes muscle weakness; pemphigus vulgaris (PV), a chronic skin disease characterized by severe blistering of the skin; and immune thrombocytopenia (ITP), a form of ecchymosis and bleeding Chronic inflammatory demyelinating polyneuropathy (CIDP), a disorder of the nervous system that causes dyskinesia.

On January 6, 2021, zaiding pharmaceutical and argenx announced that they had reached an exclusive authorized cooperation. Zaiding pharmaceutical will be responsible for promoting the development and commercialization of efgartigimod in Greater China (including Mainland China, Hong Kong, Taiwan and Macao). At present, there are about 200000 patients with myasthenia gravis in China. The existing treatment options are very limited, and there are huge unmet clinical needs.

03 Mavacamten

R & D firm: Bristol Myers Squibb

Indication: obstructive hypertrophic cardiomyopathy

Market forecast: global sales of $2 billion in 2026

Antidote: mavacamten is a specific myosin inhibitor, which is undergoing clinical trials for hypertrophic cardiomyopathy (HCM). It is expected to submit a new drug application to FDA in the first quarter of 2021. Originally developed by the biopharmaceutical company myokardia, BMS bought the company for $13.1 billion in October 2020 because of the blockbuster drug in hand. Hypertrophic cardiomyopathy (HCM) is a chronic progressive disease in which excessive myocardial contraction and reduced left ventricular filling capacity can lead to debilitating symptoms and cardiac dysfunction. BMS believes that mavacanten is a potential first-class drug. Mavacanten will become the driving force of medium and long-term growth, which will bring huge business opportunities after approval.

04 Bimekizumab

R & D enterprise: UCB

Indications: Psoriasis

Market forecast: global sales of $1.6 billion in 2026

Antidote: This is another drug that comes to grab the market of adalimumab (xiumeile). Bimekizumab is a humanized IgG1 monoclonal antibody, which can selectively inhibit IL-17A and IL-17F, two key cytokines that drive inflammation. Currently, clinical trials for psoriasis (commonly known as psoriasis) are under way.

Psoriasis is a common chronic inflammatory disease, mainly involving the skin, affecting nearly 3% of the population, that is, about 125 million people in the world. This is also the main treatment area of the drug sumelor, which has been the number one drug in the world in sales for many years. With the listing of several biological similar drugs and competitive products, the sales of xiumeile are declining year by year. Bimekizumab is expected to be approved by the European Union and FDA in 2021, with sales of $1.6 billion in 2026.

UCB is a biopharmaceutical company based in Brussels, Belgium, which mainly develops drugs for immune system or central nervous system diseases.

05 TransCon hGH

R & D enterprise: ascendis

Indications: growth hormone deficiency

Market forecast: global sales of US $1.5 billion in 2026

21 antidote: transcon HGH is a human growth hormone in phase 3 clinical phase, and its development company ascendis has conducted eight global clinical trials for it. This is an orphan drug developed for rare diseases: growth hormone deficiency (GHD) in children is a serious and rare disease in which the pituitary gland cannot produce enough growth hormone. Ghd children not only showed short stature, but also had metabolic abnormalities, social psychological disorders, cognitive deficits and decreased quality of life. For decades, the conventional treatment for children with GHD has been a daily subcutaneous injection of growth hormone to improve height and metabolic abnormalities. For patients and their caregivers, heavy daily injection treatment burden leads to poor compliance and overall treatment effect.

Ascendis Pharma was founded in 2006 and is headquartered in Denmark. In China, in 2018, ascendis pharma and vivo capital jointly established Weisheng pharmaceutical, headquartered in Shanghai, with the purpose of developing and promoting the rare endocrine disease treatment program of ascendis in Greater China.

06 Ide-cel

R & D firm: Bristol Myers Squibb / Bluebird

Indications: recurrent and refractory multiple myeloma

Market forecast: global sales of US $1.5 billion in 2026

21 antidote: another blockbuster car-t product, from BMS and its partner Bluebird, is currently conducting a number of clinical trials of multiple myeloma. IDE cel submitted BLA to FDA in March 2020, which was rejected and asked for more data. After being re submitted in July, BMS announced in September that FDA had accepted its BCMA car-t cell immunotherapy idecabagene vicleucel (IDE CEL) for the treatment of relapsed / refractory multiple myeloma (R / R mm) and granted priority review qualification. At present, there are 64 products targeting BCMA, involving 21 car-t under research, including Novartis, Juno, etc. Among them, 6 products are developed by Chinese enterprises, including Nanjing legend biology, Shanghai bangyao biology, Chongqing precision biology, etc.

07 AXS-05

R & D enterprise: axsome

Indications: severe depression (MDD), Alzheimer's disease, etc

Market forecast: global sales of $1.2 billion in 2026

21 antidote: axome therapeutics is a clinical biopharmaceutical company focusing on the development of innovative therapies for central nervous system (CNS) diseases. At present, axs-05 has obtained FDA's breakthrough drug qualification (BTD) for the treatment of severe depression (MDD). Axs-05 is a new type of NMDA receptor antagonist, which is composed of dextromethorphan and bupropion. Axs-05 has a new mechanism of action, which is different from the current available treatment of depression. Major depression is characterized by depression, inability to feel happy, and other physical symptoms in addition to lack of energy. In severe cases, MDD can lead to suicide.

08 Avacopan

R & D enterprise: chemocentryx / VIFor

Indications: antineutrophil cytoplasmic antibody (ANCA) associated vasculitis

Market forecast: global sales of $1.2 billion in 2026

21 antidote: another rare disease drug. In September 2020, chemocentryx announced that FDA accepted the new drug application (NDA) of this drug. Avacopan is an oral selective complement 5A receptor inhibitor. It is an oral small molecule drug used to treat ANCA associated vasculitis, which is a rare and serious autoimmune disease. The FDA has also awarded it the title of orphan drug.

09 Voclosporin

R & D enterprise: Aurinia

Indication: lupus nephritis

Market forecast: global sales of $1.1 billion in 2026

Antidote: voclosporin is a new type of research-based oral drug therapy. Its indications for lupus nephritis (LN) are chronic, progressive renal inflammation, and one of the most serious complications of autoimmune disease systemic lupus erythematosus (SLE). Ln is a renal inflammation caused by SLE, which represents the serious progress of SLE. The disease is highly heterogeneous and affects a wide range of organ and tissue systems. Its developer Aurinia pharmaceuticals is a biopharmaceutical company from Canada. At the end of 2020, Aurinia announced a cooperation and license agreement with Otsuka pharmaceutical for the development and commercialization of voclosporin in Europe and Japan. Otsuka is expected to submit a marketing license application (MAA) to the European Drug Administration (EMA) in the second quarter of 2021, and will also submit an application to the Japanese drug and medical device Agency (PDMA) in the future. Voclosporin is currently under FDA review.

10 Abrocitinib

R & D company: Pfizer

Indications: atopic dermatitis

Market forecast: global sales $1 billion in 2026

Antidote: the drug is a new generation of oral Jak1 inhibitors, is an oral small molecule drug, has been awarded the FDA breakthrough therapy title. Atopic dermatitis is a chronic skin disease and one of the most common chronic recurrent skin diseases in children. It affects up to 10% of adults and 20% of children worldwide.

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