Thyroid cancer field to add heavy products Zezi, cornerstone, baiji leading domestic innovation!

With the increasing incidence, thyroid cancer has received more and more attention! 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.
is on the rise The global incidence of thyroid cancer is estimated to be about 67,000 per 100,000, according to IARC, an international agency for research on cancer in 2018, and 190,000 (194,232) new cases each year in China.
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-like 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) The degree of harm of thyroid cancer and mutant genotyping Clinically found that the vast majority of thyroid cancer can be surgically and standardized treatment to achieve the purpose of disease control, but there are still some poor degree of differentiation, aggressive, iodine is not ideal differentiation of thyroid cancer and myelin cancer or non-differentiated cancer and other incurable thyroid cancer is not ideal, survival rate significantly decreased, 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%;
Figure 2.1 Thyroid cancer-related gene mutation points (Photo: Molecular Alterations in Thyroid Carcinoma. doi.org/10.1016/j.path.2019.08.002) Are currently approved by the U.S. FDA for the treatment of thyroid cancer in about seven targeted drugs.
original variety was the first multi-target drug, soraphinib, 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 2020 Newly Listed Species Selpercatinib May 2020, FDA Approves Rexo Oncology RE The T inhibitor Selpercatinib is used in adults with thyroid myeloid 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 therapy and radioactive iodine refractication.
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.
domestic RET inhibitor globalization and thyroid cancer drug development statistics Foreign countries 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: Zetam BioThe domestic development of clinical adaptation to thyroid cancer, the fastest progress is the development of Zenaphini, which is the highest stage of 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 Source: 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 (Photo:) Sitravatinib, originally developed by Mirati Therapeutics and entering Phase III (FDA) clinical adaptation, is also NSCLC;
Figure 5.3: The domestic development status of Sitravatinib, Baiji Shenzhou (Image Source:) And in addition to the above-mentioned RET inhibitor development status is higher, thyroid cancer drug development process is fast enterprises and related varieties, the domestic development of RET inhibitors and Shenyang QBH-196 developed by the University of Pharmacy, as well as HA121-28 of Shi medicine, and thyroid cancer treatment drugs, Hutchison Whampoa, Zhengda Tianqing, Fuhong Hanxuan, Pharmaceutical Mingkangde and so on have product layout.
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