Pyridine has been fully approved, and HER2 plus breast cancer treatment has entered a new era.

Recently, Hengrui Pharmaceuticals independently developed a class of 1.1 innovative drug pyridine has been fully approved by the State Drug Administration.
another milestone after the star drug received conditional market approval in 2018.
From the initial research and development to the successful listing, pyridine after nearly a decade, repeatedly on the top international academic stage, the global pharmaceutical industry has been widely recognized, breaking the import of drugs on the domestic anti-HER2 field for many years monopoly, so that the chinese people for the rise of China's original research and excitement.
, in the two years since its launch, pyridine has benefited more than 20,000 patients, and many families have been reborn as a result of pyridine.
can be said that the full approval of pyridine has an important impact on China's drug review reform, clinical diagnosis and treatment and pharmaceutical innovation.
The 2018 approved listing of pyridine is based on the results of Phase II clinical trials, a national multi-center trial in which the study group was pyridine nicah, and the control group was Rapatinegakapatin, which was randomly divided into two groups of 128 patients. the results of
confirmed that the efficacy of the pyridine group was significantly better than that of the control group, regardless of the objective remission rate and clinical benefit rate, especially in the PFS, the study group was 18.1 months, while the control group was only 7 months, extended by 11.1 months, and the HR value was less than 0.4.
with the release of two large-scale Phase III studies, PHENIX and PHOEBE, pyridine has been fully approved by the State Drug Administration, becoming the first anti-tumor innovative drug in China to be fully approved after being listed through the priority review channel.
the design of the PHENIX study demonstrated the efficacy of the contrasting chemotherapy after the failure of the treatment of querto-bead monotherapy and yew, pyridine plus capetabin.
summary of the ASCO2019 conference, the results of the PHENIX study, Phase III data for the second-line treatment of Her2 plus breast cancer patients, were published.
Analysis results of 279 cases of HER2 plus metastatic breast cancer who had previously been treated with yewane and quercetabin monotherapy in China: "Mid-level patients with pyridine and capetambin group (n - 185)" The non-progressive lifetime was significantly longer than that of the placebo-caperabin group (n s 94) (11.1 vs 4.1 months), and the objective response rate was significantly higher (68.6% vs 16.0%).
PHENIX study has been published in full in the English-language journal Translational Breast Cancer Research.
addition, the PHOEBE study was included in the 2020 ASCO Conference Report, which significantly extended the PFS (12.5 vs. 6.8 months) compared to Rapatini and Capetamin.
the study of pyridine in other tumors is also under way, and the JCO journal published a study of the treatment of her2 mutation, advanced lung adenocarcinoma, and the results are still very good.
In addition, in the clinical design of PHENIX, we have seen the advantages of combined drug, and we have 71 patients are treated with pyridine monotherapy, so this full approval can also prove the rationale for the future use of pyridine and future joint use with other drugs forward-looking.
In addition, a recent real-world study was also published, the study screened a total of 232 patients, of which 168 met the inclusion criteria, the middle follow-up time of 7.3 months, the overall population mPFS up to 8.07 months, from the baseline characteristics, three-line and above patients accounted for 56%, internal organs and brain metastasis accounted for 82%, and 23% of patients with brain metastasis.
32% of patients with third-line and above have received similar TKI lapatini treatment.
Another 32% of patients who had previously used capetambin and received pyridine in this study were treated with pyridine in combination with other medications, so it is not easy for such patients who have previously been multi-line treatment and have heavy tumor loads to show good efficacy.
For patients with third-line and above, sub-group analysis showed that mPFS was 7.6 months, and horizontal pairs were relatively better than other similar studies, TH3RESA study: T-DM1 6.2 months, SOPHIA study: Magtoxi monotherapy 5.8 months, NALA study: Nairatine Ni/Lapatini and capetambin mPFS-lt; 6 months, while pyridine can reach 7.6 months, it is a unique, and the real world population of patient treatment history is more complex, so from the drug accessibility and for some high-risk advanced patients, the use of pyridine can also greatly improve the survival benefits of patients.
In this year's CSCO guidelines list pyridine as one of the first-line treatment options, the state has also approved pyridine to enter the health insurance source according to the current adaptive disorder: the end of the network !-- content display - !-- to determine whether the end of the login . . .