Good News on Listing | Frost & Sullivan Congratulates Nuo Cheng Jianhua Medicine Co., Ltd. on Successful Listing on the Sci-tech Innovation Board

Nuocheng Jianhua Medicine Co., Ltd. (hereinafter referred to as 'Nuocheng Jianhua Medicine') was successfully listed on September 21, 2022, with an issued share number of 1.76432 billion shares, and an issue price of 11.03 yuan per share.

The company is an innovative pharmaceutical enterprise focusing on areas such as oncology and autoimmune diseases, and has currently established a product pipeline targeting multiple popular targets. As an innovation-driven company, the company takes it as its responsibility to improve the quality of life and health levels of all humanity, guided by unmet clinical needs in the global pharmaceutical market, with the goal of developing the most breakthrough potential best-in-class or first-in-class drugs. Under the leadership of a management team with rich experience in R&D, production, and commercialization, an integrated biomedical platform has been constructed, balancing R&D quality with speed, and establishing a product pipeline that is highly innovative and risk-balanced, covering multiple highly promising hot targets. Frost & Sullivan has long been monitoring the global and Chinese biomedical industries, publishing a large number of research reports, which are widely cited in the prospectuses of leading science and technology innovation board listed companies in the industry, helping clients accelerate their growth.

In the Chinese pharmaceutical market, the sales of anti-tumor drugs have been showing a steady growth trend in recent years. From 2016 to 2020, the market size reached RMB 1975 billion in 2020, with a compound annual growth rate of 12.1% over the past five years. The progress in cancer treatment methods has also led to an upward trend in the Chinese anti-tumor drug market over the next few years. It is estimated that the Chinese anti-tumor drug market will reach RMB 4162 billion by 2025, with a compound annual growth rate of 16.1%, and reach RMB 6831 billion by 2030.

Autoimmune diseases are a type of illness where the body's immune system mistakenly attacks itself. These conditions may be related to abnormal low or high activity of the immune system. There are approximately 100 different types of autoimmune diseases, which can affect almost any part of the body, including the heart, brain, nerves, muscles, skin, eyes, joints, lungs, kidneys, glands, digestive tract, and blood vessels.

Common autoimmune diseases include rheumatoid arthritis, ankylosing spondylitis, psoriasis, lupus erythematosus, etc. These diseases usually have a recurrent course and are characterized by a chronic protracted process. The main drugs for treating autoimmune system diseases include non-steroidal anti-inflammatory drugs, glucocorticoids, and immunosuppressants. Currently, there is no cure for autoimmune diseases.

With a deeper understanding of the pathophysiology and related biological pathways of autoimmune diseases, there is hope that more innovative biologics and small molecule targeted drugs will be developed in the future to offer patients with autoimmune diseases more treatment options, such as anti-IL-6 antibodies and BTK inhibitors. These newly developed drugs not only provide more available medications for patients with autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus but also help solve more therapeutic areas.

China has a large number of patients with autoimmune diseases, and the number is reported to be on the rise. In 2020, there were approximately 1.04 million patients with systemic lupus erythematosus, 430,000 with ulcerative colitis, and 5.96 million with rheumatoid arthritis in China. With the development and improvement of diagnostic techniques for autoimmune diseases in our country, the market demand for healthcare services will be stimulated in the coming years. It is estimated that the overall market size will reach $8.7 billion by 2025, with a compound annual growth rate of 28.1% from 2020 to 2025.

BTK is a cytoplasmic non-receptor tyrosine kinase that plays an important role in the development and physiological functions of immune cells involved in the pathological process of autoimmune diseases, such as B cells, macrophages, and microglia. After the transformation of B-cell lymphoma into cancer, BTK becomes abnormally active. The activation of the BTK signaling pathway sends signals to initiate the growth of malignant B-cell tumor cells and plays a significant role in the growth, migration, and other processes of B-cell malignancies.

BTK inhibitors act by targeting the BCR signaling pathway, binding to BTK and inhibiting its own phosphorylation. This prevents the activation of BTK, thereby blocking cell conduction and inducing apoptosis. It suppresses the growth of malignant tumors, achieving a control effect on the development of B-cell tumors. It has become a popular target for the treatment of hematological malignancies and autoimmune disorders.

Currently, there are mainly three drugs in the Chinese BTK inhibitor market: ibrutinib (Janssen), zanubrutinib (BeiGene), and olbitalimab (Novartis). Since the first BTK inhibitor was approved in China in 2017, the Chinese BTK market has grown rapidly, reaching 1.3 billion yuan in 2020 and is expected to grow to 131 billion yuan by 2025 at a compound annual growth rate of 58.6%. This market is expected to expand to 225 billion yuan by 2030, with a compound annual growth rate of 11.5% from 2025 to 2030.

Fibroblast growth factor receptor (FGFRs) are highly conserved, widely distributed transmembrane tyrosine kinase receptors containing four subtypes (FGFR-1, 2, 3, and 4). Dysregulation of FGFR signaling leads to cancer development, proliferation, survival, and metastasis. Almost every malignant tumor has FGFR aberrations (amplification, mutation, rearrangement), with 7.1% of solid tumors having FGFR aberrations. The most common are in urothelial carcinoma (31.7%), cholangiocarcinoma (25.2%), hepatocellular carcinoma (30.0%), breast cancer (17.5%), and gastric cancer (6.7%).

FGFR inhibitors work by blocking the activity of intracellular kinases binding to ATP, thereby disrupting downstream signaling pathways. This leads to anti-tumor effects such as anti-cell proliferation and anti-angiogenesis. Abnormalities in the FGFR signaling pathway have become an important cause of various tumors and show promise as new targets. At the same time, activation of the FGFR signaling pathway can also lead to resistance in some tumor cells to targeted therapy. Therefore, FGFR has become a hot area in the research and development of tumor-targeted drugs.

Currently, three FGFR inhibitors have been approved for two different indications. Erdafitinib Balversa has been approved by the FDA for the treatment of metastatic urothelial cancer, while pemetrexed and gefitinib have been approved for the treatment of cholangiocarcinoma.

TRK kinases are believed to be involved in the growth, differentiation, and apoptosis of neuronal cells. Under normal circumstances, all TRK proteins have a similar extracellular domain structure but different ligands. These proteins are usually expressed in the nervous system and are activated when stimulated by signals, leading to phosphorylation of TRK and the activation of downstream signaling pathways. When TRK dysfunction leads to excessive activation of downstream channels, it may result in cancer development. TRK kinases are overexpressed in melanoma, non-small cell lung cancer (NSCLC), thyroid cancer, malignant myeloid leukemia (AML), malignant glioma, astrocytoma, colon cancer, and other cancers, and this overexpression is closely related to tumor cell migration.

There are mainly three types of TRK inhibitors. One is the tyrosine kinase inhibitor, which is a TKI drug that can inhibit multiple kinases. There are many marketed products, including entrectinib, crizotinib, larotrectinib, ponatinib, MGCD516, TSR-011, etc., among which entrectinib holds a leading position. Another type specifically inhibits TRK, with lapatinib as the representative drug. There is also a class of non-specific TKIs that may target TRK fusion, including cabozantinib and regorafenib.

The market size of TRK inhibitors in China is expected to reach $0.1 billion in 2022, and it is projected to grow at a compound annual growth rate of 180.4% to reach $2.1 billion by 2025, and then increase at a compound annual growth rate of 39.9% to reach $11.4 billion by 2030.

CD19 regulates the development, proliferation, and differentiation of B cells through both B cell receptor (BCR)-dependent and BCR-independent mechanisms. Currently approved CD19-targeted therapies are mainly focused on DLBCL and B-ALL. As a specific surface marker of normal and malignant B lymphocytes, CD19's limited expression in normal tissues and extensive expression in B lymphoma cells reduce off-target toxicity to a certain extent, making it a highly promising target molecule for immunotherapy against B lymphoma malignancies.

The number of new cases of B-cell malignancies in China is continuously increasing. In China, the number of patients with DLBCL approved for CD19 was 211,000 in 2020, and it is expected to reach 259,000 and 299,000 respectively by 2025 and 2030. At the same time, the indications for CD19 targeted therapies are also expanding beyond B-cell malignancies. This will further expand the patient pool for CD19 targeted drugs. The growing patient population will increase market demand for CD19 targeted drugs, thereby promoting the development of the CD19 targeted drug market.