Innovation trends to watch in the life sciences

CD3 is a transmembrane protein on the surface of T cells, which can bind to TCR on T cells to form a receptor complex to activate T cells, and is the number one target of dual-antibody drug development. CD3 bisecific antibodies can redirect CD3+T cells to the tumor site, which is a promising immunotherapy strategy for the treatment of hematological malignancies and solid tumors. As of December last year, 333 CD3-related projects were in the pipeline worldwide. Experimental data show that the global CD3 target track is progressing rapidly, and there are significant breakthroughs in the treatment of leukemia, diabetes, and cancer.

TIGIT, which stands for T cell immunoglobulin and ITIM domain protein, is a co-inhibitory receptor and is considered to be one of the most promising immune checkpoints after PD-(L)1. Studies have found that TIGIT is highly expressed in a variety of malignant tumors and is closely related to the prognosis of patients. TIGIT targeting MAB can effectively restore T cell function, and then play an anti-tumor role. In 2023, leading pharmaceutical companies, including Roche, will continue to publish the latest research data on TIGIT therapy.

Dozens of blockbuster new drugs are on the verge of approval

In 2022, the FDA's Center for Drug Evaluation and Research (CDER) approved 37 innovative drugs. Among them, 21 were first-in-class innovative drugs, accounting for 57%, the highest in the past year. Oncology remains a hot area for new drug development, followed by nervous system and skin drugs, and a variety of rare diseases have also ushered in new treatment options.

In 2022, the China Food and Drug Administration (NMPA) approved a total of 49 new drugs, of which 30 were imported and 19 were domestically produced. Antitumor drugs topped the list, accounting for 49%; Drugs to treat COVID-19 ranked second, accounting for 10.2%; This was followed by new drugs for blood diseases, new drugs for non-COVID-19 infections and new drugs for immune system diseases.

In the New Year, exa-cel, a gene-editing therapy for sickle cell disease (SCD); mavorixafor, the first drug for patients with the rare disease WHIM syndrome; gepotidacin, an innovative oral antibiotic for acute cystitis; LY3209590, a long-acting insulin for type 2 diabetes; and anti-April monoclonal antibody for immunoglobulin nephropathy More than 10 innovative drugs such as KarXT, the first new drug for schizophrenia in the past year, Tirzepatide, a drug for obstructive sleep apnea, and gene delivery therapy for Duchenne muscular dystrophy are expected to be approved by the FDA.

Meanwhile, Jacotinib, a new class of JAK inhibitors for the treatment of moderate and high-risk myellofibrosis; Herkelenel, a cell therapy product for B-cell acute lymphoblastic leukemia; Detrastuzumab for injection for breast cancer; ritlecitinib, a selective JAK3 inhibitor for alopecia areata; and Nu, a small molecule CGRP receptor antagonist for adult migraine More than 20 new drugs, such as rtec, Mounjaro, GIP and GLP-1 dual-target receptor agonist for the treatment of type 2 diabetes, and Vyvgart for the treatment of myasthenia gravis, are also expected to be approved by CDE, NMPA and other relevant institutions in the domestic market.

These new drugs mainly involve the fields of tumor, autoimmune diseases, anesthesia and analgesia, cardiovascular and metabolic diseases, ophthalmology and rare diseases, including small molecule targeted drugs, bispecial antibodies, antibody-coupled drugs (ADC), siRNA therapy, CAR-T products and other types.

Under the influence of macro factors such as the impact of the epidemic and the downward trend of the capital market, the medical investment and financing market in 2022 has shown a relatively cold trend. As the year 2023 approaches, WHO will have a new definition of whether the COVID-19 pandemic will constitute a global health emergency, and life sciences investment is expected to enter a new historical cycle. At the same time, the continuous promotion and breakthrough of innovative technologies, therapies, targets and even drugs have also injected confidence in the investment and financing of the life science field this year, the investment of the head fund in biology will continue to increase, and the investment in biomedicine in the future will follow the new law.