After 5 years in the field of thyroid cancer to add a heavy product, Ze-Chi, cornerstone, Baiji leading domestic innovation!

Read: In May 2020, the FDA approved the highly selective RET inhibitor Selpercatinib, a heavyweight product that targets thyroid cancer after a five-year erratic cancer drug! Thyroid cancer has received increasing attention as the incidence of thyroid cancer has increased! In May 2020, the FDA approved the highly selective RET inhibitor Selpercatinib, a heavyweight product that targets thyroid cancer five years later! Domestic, whether for thyroid cancer this adaptive disease, or RET this tumor target, have a well-known pharmaceutical layout, and is close to the harvest period.
1 incidence is on the rise, according to the International Agency for Research on Cancer IARC in 2018, the global incidence of thyroid cancer is estimated to be about 67,000 per 100,000;
According to the tissue source and degree of differentiation of the tumor, thyroid cancer is divided into thyroid papyroid cancer, thyroid figular cancer, thyroid undifferentiated cancer and thyroid myelin cancer, while differentiated thyroid cancer (DTC) originated from thyroid filtration cells, is the most common type of thyroid cancer, accounting for more than 95% of the total thyroid cancer.
1.1 Global Thyroid Cancer Incidence Profile (Photo: Nature Reviews. Endocrinology. doi.org/10.1038/s41574-019-0263-x)2. Clinical findings of thyroid cancer and mutated genotypes, the vast majority of thyroid cancer can be achieved through surgery and standardized treatment The purpose of controlling the disease, but there are still some poor degree of differentiation, aggressive, iodine is not ideal differentiation thyroid cancer and myelin-like cancer or non-differentiated cancer and other incurable thyroid cancer is not ideal, the survival rate decreased significantly, is the current diagnosis and treatment of difficulties and hot spots.
From the perspective of primary cancer genes, common genetic mutations include: 1) BRAF mutation thyroid papyroid cancer patients BRAF positive rate of 45%, for BRAF mutation positive, 90% with V600E recombination, often associated with thyroid tumor invasion, lymph nodes and distant metastasis and other tumor progression; The T/PTC rearm RET gene is closely related to system or somatic cell mutations in thyroid myelin-like cancer, reT/PTC is about 7%;
2.1 Thyroid cancer-related gene mutation site (Photo: Molecular Alterations in Thyroid Carcinoma. doi.org/10.1016/j.path.2019.08.002) 3. Currently, about 7 targeted drugs approved by the FDA for thyroid cancer treatment have been listed.
original variety was the first multi-target drug, soraphine, which went on sale in 2015, and its adaptive "local recurrence or metastasis, radioactive iodine recurring differentiated thyroid cancer" was adopted by priority review in 2013.
, in July 2017, the SFDA approved its treatment for radioactive iodine refracilable differentiated thyroid cancer.
sorafini, the FDA approved the listing of Vandetanib, Cabozantinib, Trametinib, Dabrafenib and Lenvatinib, as well as adaptations to the direction of thyroid cancer.
five years after Levatinib went on sale in 2015, in May 2020, the field of thyroid cancer was further targeted at the new drug Selpercatinib for the treatment of "RET mutant thyroid myelin cancer and RET fusion positive thyroid cancer".
PS: Most of the seven Tini varieties mentioned above are now $1 billion varieties.
Table 3.1 2005-2020 Thyroid Cancer Targeted Treatment/Listing Drug Statistics 4. 2020 Newly Listed Species Selpercatinib May 2020, FDA Approves Loxo Oncology THE RET inhibitor Selpercatinib is used in adults with thyroid myelin-like cancer and pediatric patients over 12 years of age who require systemic treatment for advanced or metastatic RET gene mutations, as well as in adults with thyroid cancer and children over 12 years of age who require systemic treatment and radiation iodine.
the fda's breakthrough therapy certification in 2018 and the FDA's priority review of the variety in January 2020.
addition to the expansion of the drug pipeline for the treatment of thyroid myelin cancer, it is worth mentioning that the listing of Selpercatinib has played an important positive role in the development of RET high-choice inhibitors.
As mentioned above, "BRAF mutation, RET refrule, RAS mutation" is manifested in many thyroid cancers, and RET ret ranking is also active in most of the seven drugs mentioned above, but the difference is that Loxo Onc Selpercatinib, developed by ology, is a more targeted and highly selective RET inhibitor, giving a more direct proof of the role of RET in tumor development, and the development of RET inhibitors will be more dynamic as a result.
5. The globalization of domestic RET inhibitors and thyroid cancer drug development statistics abroad, whether it is RET inhibitors, or for thyroid cancer as an adaptive drug development, although the progress is not fast, but steady progress.
, although there are no major innovative varieties on the market, but whether it is RET inhibitor research and development or commercial development, as well as thyroid cancer drugs screening, has been very good results.
and focus on these two aspects of pharmaceutical companies, are well-known innovative pharmaceutical companies in China.
Domestic Thyroid Cancer Drug Development: The domestic development of clinical adaptation to thyroid cancer, the fastest progress for the development of Zenaphini, its highest stage is NDA, and has not yet been listed in 2020 the latest release of the domestic liver cancer treatment guidelines, its thyroid cancer adaptation has now entered clinical phase III.
Figure 5.1: Zetam Bio-Donabini Domestic Development Status (Photo:) ReT Inhibitor Globalization Process: Keystone, Baiji Domestic Pharmaceutical Company's Development of RET Inhibitors, the world's fastest-growing Pralsetinib (non-small cell lung cancer) developed by Keystone Pharmaceuticals, is now in the NDA phase (FDA);
Pralsetinib, originally developed by Blueprint Pharmaceuticals, completed clinical Phase I/II trials in 2017 and initially completed the validation of safety, tolerance, pharmacy generation and ller effects;
Figure 5.2: Keystone Pharmaceuticals' high-stage pipeline (pictured: ) Sitravatinib, originally developed by Mirati Therapeutics and entering Phase III (FDA) clinical adaptations, is also NSCLC;
Figure 5.3: The domestic development status of Sitravatinib, Baiji Shenzhou (Photo Source:) and in addition to the above-mentioned RET inhibitor development status is high, thyroid cancer drug development process is fast enterprises and related varieties, the domestic development of RET inhibitors and Shenyang medicine QBH-196 developed by the University of Science and Technology, as well as HA121-28 of Shi medicine, and thyroid cancer treatment drugs, Hutchison Whampoa, Zhengda Tianqing, Fuhong Hanxuan, medicine Mingkangde, etc. have product layout.
: 1. Treatment of Aggressive Thyroid Cancer. The Nature Reviews 12 (2019) 943-9502. Endocrinology. 3. FDA website 4. MolecularAtions in Thyroid Carcinoma. 5.RET fusions in solid tumors. 6.The molecular basis for RET tyrosine-kinase resedors in thyroid cancer. 10.1016/j.beem.2017.04.0137.RET Fusion: Joining the Ranks of Targetable Molecular Drivers in Non-Small Cell Lung Cancer.8.Dysregulated RET Signaling in Thyroid Cancer. doi: 10.1016/j.ecl.2008.02.0069.Molecular pathogenesis and mechanisms of thyroid cancer. nature/reviews. doi:10.1038/nrc343110. CNKI Literature 11.Pharmaproject Date/Cortellis Date12.Zee-Sein Pharmaceuticals Official Website 13.Keystone Pharmaceuticals Official Website 14.Baiji Shenzhou Official Website.