HER2 drug market melee! How did The Third Life Seputin break out?

Pharmaceutical Network July 30 , the development of anti-HER2 targeted treatment drugs , so that HER2-positive breast cancer patients have a significant improvement in the overall prognosis .
at present, anti-HER2 treatment drugs mainly include quralmon, patojumonort, T-DM1, pyrith and so on.
with the accelerated launch of biolike imitation and me-too innovative products, the expanding number of drug varieties on the market side, while enriching clinical options, but also brings the challenge of rational drug use.
not long ago, Sansheng Pharmaceutical Announcement Company's first Independent Research and Development innovation anti-HER2 monoanti-resisting was officially approved by the State Drug Administration for listing, as a new HER2 monoantinodrug, its future clinical application and value mining, has attracted industry attention.
the promotional materials of Sansheng Pharmaceuticals, which are still in doubt for the ADCC effect, innitosa submitted a listing application for class 2 new drugs in September 2018 and was included in the priority review process in November 2018.
the Fab segment of initomonol is consistent with quitonal monotonica, while the Fc segment is modified and optimized for production processes, with a stronger ADCC effect, so it is not a biosimilar drug of Herceptin (quertal monotol monotortagain), but a targeted innovative biological drug developed by Sansheng Pharmaceuticals.
, the research reporter found that in an article entitled "Anti-HER2 humanized monoclonal antibody drug key quality attribute evaluation", the researchers recombined anti-HER2 humanized monoclonal antibody MAb302 (commodity name "Septine") of the purity, impurities, structure, activity and other key quality properties of in vitro experimental research, and compared with the original biological drug quralbead suptone resistance.
for the difference in ADCC effect, the study published in vitro experimental data results, the ADCC effect of quercem monotol is 90% of initomonotag.
however, from the analysis data, it can be found that in the process of in vitro experimental research, whether it is ADCC activity or affinity with FC receptors, including fc-RIIIIII.a two subtypes (158V and 158F) receptor binding dissothing ability, the researchers believe that initusaandand and quoctarenostol monotolsa no quantitative differences in experimental data.
, in vitro experimental data show that the ADCC effect of innitomonotol contrasted quralmto monobamong is slightly higher, but the researchers do not believe that this small difference in in vitro experiments will result in a substantial difference in the ADCC effect of the two drugs.
is why the researchers concluded that there was no significant difference between the activity-related mass properties of antibody-dependent cell-received cytotoxic action activity (ADCC effect), antigen affinity, FC receptor affinity, and reference biologics." In addition to
, although Sansheng Pharmaceuticals has successfully completed the I, II, III clinical trials of initu monotosyre in strict accordance with the drug registration regulatory path, and successfully realized the product market, but as an innovative product, its advocacy of "ADCC effect advantage", only in vitro experimental data research, still lack sufficient clinical evidence-based basis.
clinical experts said that in the course of clinical practice, for patients with advanced breast cancer, there is often an immune deficiency or immunosuppressive state, improve the ADCC effect and long-term clinical benefits between the transformation altogether, there is uncertainty.
on the HER2 drug innovation track, the data on Margetuximab, another Fc segment that retrofitted HER2 antibody drug, is somewhat more convincing.
in vitro experimental data can be seen, using different research methods, Margetuximab and quercetzumab in vitro experimental data there are significant differences: in fc-based RIIIIIIa affinity performance, 158V subtype difference of 4.3 times, 158F subtype difference of 5.3 times.
in subsequent clinical trials, Margetuximab's clinical findings also confirmed the clinical benefits of significant discrepancies in vitro trials, and the results of the "SOPHIA Study" published last year at ASCO's annual meeting drew industry attention: compared to the control group, margetuximab's PFS extension of chemotherapy group reached the primary endpoint (mPFS, 5.8 vs. 4.9 months, HR.76, 95% CI 0.59 to 0.033.
Although the academic community is statistically significant for mPFS extension, the difference is relatively small, there is some industry discussion, but the possible clinical benefits of subgroup patients with different genotypes deserve further exploration has been generally recognized.
market challenges can not be ignored at present, in the FIRST and second-line treatment of HER2-positive breast cancer, clinical guidelines have a clear path of treatment drug recommendations.
in the Breast Cancer Guidelines published by the Chinese Society of Clinical Oncology, qutozumab combined chemotherapy was recommended as her2-positive preoperative treatment for breast cancer (Grade I recommended), HER2-positive postoperative-assisted targeted therapy (Grade II recommended), and HER2-positive advanced (recurrence metastasis) breast cancer anti-HER2 first-line and second-line treatment regimen (I-recommended).
and in the back of the treatment, to rapatinib, pyritinib, innatinib and other representative of the oral tyrosine kinase inhibitors, as well as T-DM1 or continue HER2 targeted treatment, a variety of chemotherapy drug therapy, clinical choice although the lack of standard answers, and the ongoing drug, has greatly enriched the selectivity of clinical drugs.
in the words of clinicians: "Before HER2 breast cancer everyone in clinical lying is drug-free, now too many drugs to take the eye!" "The industry generally believes that in the future, at the market and clinical level, a truly patient-centered focus, focus on the long-term clinical benefits of the real world, prudent health technology assessment, scientific clinical decision-making, rational replacement, serious use and healthy competition, there is no doubt that the policy level needs further refinement, in encouraging innovation while strengthening fairness and fairness, so as to guide rational research and development."
at present, the domestic listed anti-HER2 monoidis is mainly Roche's quordal monoidat (herceptin), patujus monoidat (Padert), and in January 2020, Roche antibody conjugate drug Enmiqual savirus (Hercel, T-DM1) was also approved for listing in China.
a series of evidence-based studies, such as CLEOPATRA, PUFFIN, PERUSE and RePer, make the status of quercetzumab in the field of HER2-positive metastatic breast cancer treatment difficult to shake.
further data from the Drug Review Center (CDE) of the State Drug Administration show that more than 10 domestic enterprises are actively carrying out research and development of qutodzumab similar drug products, of which Fuhong Hanxuan is the fastest progress, the latest news shows that Fuhong Hanxuan's Qutozhu singtag has just won the European Union listing Approval (EU commodity name: Zercepac), the domestic listing is within reach, in addition, there are a number of similar pharmaceutical products in the clinical phase of Phase III, respectively, Shanghai Institute of Biological Products, Jiahe Biology, Zhengda Tianqing, Hualan Gene, Haizheng Pharmaceuticals, Anke Biology and so on. In addition to
, in terms of small-molecule drugs, the new drug her1, HER2, HER4 tyrosine kinase irreversible oral inhibitor developed in China, was approved in 2018 for the treatment of HER2-positive advanced breast cancer.
PHOEBE studies show that for metastatic breast cancer patients who have previously used quralsandandatagandadine drugs, receiving pyridine joint capedabine treatment compared to rapatinib can significantly prolong the patient's progression-free survival and continue to impact on front-line treatment.
as the new drug listed initatosa, in order to meet regulatory approval requirements, its Phase III registered clinical research selected a more secure clinical trial program, evaluated the clinical efficacy and safety of ininitu synth-synchronous/sequential joint Changchun Ruibin treatment of HER2-positive metastatic breast cancer.
results showed that the median PFS in the trial group was 39.1 weeks and the median PFS in the control group was 14.0 weeks in terms of non-progression survival (PFS) of the main efficacy indicators.
However, due to the small clinical trial data, in the initu monoidal drug specification, only mentioned the participants in Phase III clinical trials as "past chemotherapy program stalker no more than 3 lines", specific patient screening is likely to be more mixed, clinical front and back line of the specific use of the situation, still need to be more clearly answered.
also according to the reporter, Initu monotoantisis in the approved listing 12 days after the prescription sales in Beijing, Jiangsu, Anhui, Shandong, Zhejiang five provinces and cities, sales price close to 1600 yuan / 50mg / branch.
at 50 kg of weight, a cycle requires 400 mg, regardless of the gift of medicine, the direct cost of treatment more than 12,000 yuan.
industry sources point out that Sepstein's pricing is clearly a consideration for cutting prices into health insurance, which could be more than 60 percent if it wants to achieve similar health insurance treatment in the race for qurillas.
in encouraging innovation, since the reform of the review and approval system, the domestic drug regulatory policy has released a huge advantage, but also to many pharmaceutical enterprises have brought market dividends.
However, after the product market, focus on fair and equitable and clinical value, there are still problems that need to be solved.
for the rapid listing of initu monoid, product prices, differentiation promotion, clinical development, medical insurance negotiations, as of the draft, Sansheng Pharmaceuticals has not given a clear response to specific issues.
industry generally believes that in the field of cancer treatment, including PD-1/L1 inhibitors, anti-angiogenesis drugs, anti-HER2 drugs, the number of clinical trials is increasing, especially in the field of breast cancer anti-HER2 treatment, auxiliary, new auxiliary, late clinical trials have been widely concerned, initusedagain as a brand-new anti-HER2 drug, must be based on the clinical use of the drug, around the clinical treatment path to carry out further joint drug research, mining clinical use.
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