Both products are to be given priority review of how the star biotech/old MNC rides the storm.

The first is the injection of the Virdixito monoantigen.
The new drug, developed by Rongchang Bio to treat patients with locally advanced or metastatic stomach cancer, including gastroesophageal adenocarcinoma, has been accepted and included in the priority review, according to the CDE website.
and notably, it is also the first self-developed antibody-drug association (ADC) in China to submit an application for a new drug.
the second drug is platini capsules, declared by Keystone Pharmaceuticals.
this is a powerful RET inhibitor.
the name may seem strange, it is already a focus area for multinational drug giants such as Lilly and Roche.
The Platini capsule, which is to be included in the priority review, was developed by Keystone Pharmaceuticals in cooperation with NASDAQ-listed Blueprint and announced in early July that it had also submitted a listing application for the new drug to the FDA.
note that the priority reviews of the two products took only six and five days, respectively, from application to publicity.
the past, it has been the norm to queue in priority review queues for months or even months.
E drug managers' statistics on nearly 100 priority reviews since 2020 found that it took an average of 41 days from application to publicity.
the rapid adoption, on the one hand, shows the positive performance of the two varieties in the declaration data, and on the other hand, the national drug regulatory system for the accelerated approval of heavy new drugs, also reflected.
01 ADC market is hot, Rongchang entered the market in the immediate injection with the Virdixito monoantigen as rongchang biological core drug candidate (commodity name Aedes aig), becoming the first antibody-drug joint (ADC) to apply for market.
Antibody-Drug Association (ADC) is a hot area of global cancer drug research and development in recent years, it is made up of monoclonal antibodies, connecting sons and small molecule cytotoxic drugs, can be like a precision-guided missile to carry out precision strikes on cancer cells.
2010-2015, a wave of companies around ADC or highly involved ADC was established.
Rongchang Bio is one of them, as well as Dongyu Pharmaceuticals (2009), Therese (2010), Hangzhou Biotech (2015) and so on.
ADC drug is considered the next wave of $1 billion bomb drugs.
the FDA approved three ADC drugs in 2019.
In February 2020, Corey's Annual Report on the 2020 Drug Prediction predicted 11 new drugs (heavy drugs) that will be available in 2020 and are expected to exceed $1 billion in annual sales by 2024, including two of the three cancer drugs selected for this year's heavy bomb drug.
also according to BCG's "Breaking the Wind and Waves" released today. According to the ADC: Codirectional Blast of Small and Large Molecules report, the eight ADC drugs currently on the market are expected to contribute 75% of global sales in 2026.
that although most pipelines are still in their early clinical stages in the ADC field, the differentiation between large pharmaceutical and biotech companies is not yet evident.
but AbbVie, Pfizer, Roche, Bayer, The First Three, etc. have preempted the layout, all with more than 10 pipelines involved.
and the domestic Bayda Pharmaceuticals, Hengrui, Stone Pharmaceutical Group, Junshi Bio, Fosun and so on are also laid out.
and multinational pharmaceutical companies are imposing joint code ADC development.
, for example, AstraZeneca has reached a $6.9 billion partnership with Hertu (DS-8201), an antibody consonant drug that targets HER2, and the two companies have also jointly developed antibody consonant drug (ADC) DS-1062, which targets human nourishment layer cell surface glycoprotein antigen 2 (TROP2).
research and development of innovative pharmaceutical companies in the field of ADC in China is progressing well.
in addition to the injection of Virdixito monoantigen,
Rongchang Bio has also developed a series of ADC drugs, of which RC88 is undergoing Phase I clinical trials, and every year for the next few years there will be ADC candidates entering the clinical research phase.
and Dongying Pharmaceuticals recently announced the progress of research and development, said its self-developed HER2 targeted antibody-linked drug TAA013 has completed the critical Phase III registered clinical trial of the first patient administration.
, the main adaptive disorders studied by ADC are breast, lung and prostate cancer.
two ADC drugs are on the market in China, both of which will be approved in 2020.
one was Roche's Enmetro-Zhudao monoanti, which was approved in January 2020, and the other, Takeda's Vitoxy monoanti, which was officially listed on commercially available in China on August 6.
The product is still the only antibody-coupled drug to be marketed targeting CD30, the first fda-approved new drug for interdational large-cell lymphoma (ALCL) in nearly 40 years, and the first first first-line treatment for classic Hodgkin's lymphoma (cHL) and exocyte T-cell lymphoma (PTCL).
, the two new ADC drugs are likely to be included in medicare, according to the 2020 National Health Insurance Drug Catalog Adjustment Work Programme, released by the National Health Insurance Administration on August 17.
and the injection approved by Rongchang is mainly used in the field of stomach cancer.
it is understood that this is currently the first in the world in the third-line treatment of stomach cancer for HER2 expression of gastric cancer patients, including HER2 low expression (IHC 2 plus / FISH-) patients.
as a domestic independent research and development products, Edhi is more than twice as efficient as the existing listed drugs, is regarded by the industry as a major breakthrough in the study of new drugs for stomach cancer.
china as the world's highest incidence of stomach cancer in the country, the number of cases accounted for about 50% of the global number of patients, the market prospects are broad.
addition, Rongchang is clearly ready for the future development of the drug.
September 2018, the drug was certified as an FDA gastric cancer orphan drug, in April 2020 it received a clinical license for FDA HER2-positive localized advanced or metastatic urethra skin cancer Phase II., in July 2020 it was approved by the FDA for fast track approval, and a phase II./III clinical study of multiple adaptations is planned for 2021.
02 Cornerstone VS Lilly, competing for the RET domestic market and this time included in the proposed priority review of the cornerstone of the pharmaceutical industry Platini capsules, has been due to the layout of the two giants has become a "net red."
their bid for RET drugs once again reflects the urgency and desire of drug companies to seize an innovative drug.
June 2018, Keystone Pharmaceuticals obtained exclusive development and commercialization of several drugs from Blueprint Pharmaceuticals, including Platinib, in Greater China.
In July, Blueprint Medicines entered into a global partnership with Geneneck, a member of the Roche Group, to develop and commercialize pralsetinib, which has obtained exclusive global licenses for Platini in Greater China, including Chinese mainland, Hong Kong, Macau and Taiwan, and outside the United States.
future, the two sides also plan to expand the development of pralsetinib in a variety of therapeutic areas, and have the option to cooperate in exploring the development of the next generation of RET inhibitors.
's addition would mean a head-on competition with Another giant, Lilly, in the field.
, which has been in sync with Blueprint Medecins' research and development progress, was acquired by Lilly in January 2019 for $8 billion.
, LOXO-292 has been a major product of Lilly's efforts to revive tumor pipelines.
U.S., Retevmo, a RET inhibitor from Lilly subsidiary Loxo Oncology, is one step ahead and was approved by the FDA for listing in May.
the first approved treatment specifically for cancer patients with RET gene changes.
industry describes Retevmo as "a stand-out in the crowded RET target circuit, becoming the world's first approved specific RET inhibitor, bringing the dawn of life to patients with RET mutations."
" Retevmo is primarily used to treat three types of patients, namely adult metastatic RET fusion positive NSCLC patients, adults requiring systematic treatment and patients over 12 years of age with advanced pediatric or metastatic RET mutation-positive thyroid myelin cancer, and adults with radioactive iodine incurable need of systematic treatment and adults over 12 years of age with advanced pediatric or metastatic RET fusion positive thyroid cancer.
the drug was priced at $20,600 a month, according to media reports.
this time, Keystone Pharmaceuticals' Platini capsules were preempted into the proposed priority approval.
It is understood that in China, LOXO-292 has been tacitly approved by CDE clinical trials, officially entered the clinical, adaptive disorders are: RET fusion positive solid tumor, RET mutation of thyroid myelin cancer (MTC) and other tumors with RET activation.
predictably, in the near future, Keystone and Lilly will compete for RET's domestic market.
other RET inhibitors currently under development are mostly in the early stages of clinical life, according to the Pharmadigger database.
such as Henri's Apatinib is in clinical phase II for RET fusion NSCLC adaptation, and Pfizer's sunitinib RET fusion or FGFR2 amplification for physical adaptation is in clinical phase I.
original title: Less than a week, two heavy-duty products are to be prioritized public! Star biotech VS veteran MNC, how do these varieties ride the wind and waves?