Looking at how the pharmaceutical industry in the post-epidemic era will innovate and transform from the guiding principles of anti-tumor drugs

As the new crown epidemic becomes normalized, market sentiment in the pharmaceutical sector has gradually returned to rationality
.

Since the Drug Evaluation Center of the National Medical Products Administration issued the "Clinical Value-Oriented Clinical Research and Development Guidelines for Anti-tumor Drugs" (draft for comments) on July 2, the pharmaceutical sector began to fluctuate and decline as a whole, and entered the medical insurance in November.

What is the "magic power" of a guidance document?

What is the "magic power" of a guidance document?

The "Guiding Principles for Clinical Research and Development of Anti-tumor Drugs Oriented by Clinical Values" (hereinafter referred to as "Guiding Principles for Anti-tumor Drugs") emphasizes that the development of new drugs should be based on patient needs and clinical value-oriented
.

This principle puts forward higher requirements for the research and development of innovative drugs, and aims to realize the fundamental value of new drug research and development—solving clinical needs and maximizing patient benefits

Stones from other mountains can be used for jade, how to implement the guiding principles of anti-tumor drugs?

Stones from other mountains can be used for jade, how to implement the guiding principles of anti-tumor drugs?

Looking at the new drug approvals in the first three quarters of 2021 in Europe and the United States, the US FDA and EU EMA have reviewed and approved a total of 27 new anti-tumor drugs
.

Stones from other mountains can be used to attack jade.

0 1.
Strengthen mechanism research

0 1.
Strengthen mechanism research

The US FDA accelerated the approval of Amgen’s KRASG12C inhibitor Lumakras on May 28 for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with KRASG12C mutations who have received at least one systemic treatment in the past
.

Lumakras is the world's first drugged KRASG12C inhibitor after more than 40 years of research on KRAS mutant oncoproteins

China's "Guiding Principles of Anti-tumor Drugs " clearly proposes that basic research and drug action mechanism innovation are the fundamental driving force for drug research and development
.

At the beginning of drug research and development, basic research on the mechanism of tumor occurrence and development should be strengthened, and the research on the mechanism of drug action should be strengthened at the same time.

Basic research and innovation in the mechanism of drug action are the fundamental driving force for the advancement of drug research and development

0 2.

The targeted anti-tumor drug Teppetko is used to treat adult patients with advanced non-small cell lung cancer (NSCLC) carrying the MET gene exon 14 skipping change (METex14skipping).
It is the first approved treatment in the world for the treatment of MET gene change Oral MET inhibitor for advanced NSCLC patients
.

Eli Lilly’s Retsevmo is used to treat advanced lung and thyroid cancer that are positive for RET fusion

China’s "Guiding Principles of Anti-tumor Drugs " emphasizes that in the process of anti-tumor drug research and development, attention should be paid to and continuous improvement of the matching degree between patients and therapeutic drugs, and continuously improve the accuracy of anti-tumor treatment, so that cancer patients can receive more suitable for them.
Therapeutic drugs
.

It is emphasized that in the process of anti-tumor drug development, attention and continuous improvement of the matching degree between patients and treatment drugs should be paid to continuously improve the accuracy of anti-tumor treatment so that cancer patients can receive treatment drugs that are more suitable for them
.

0 3.
Pay attention to the dynamic changes of treatment needs

0 3.
Pay attention to the dynamic changes of treatment needs

With the development of targeted therapies, anti-tumor treatments have become more and more precise, and the effectiveness of anti-tumor drug treatments has gradually improved, but the treatment needs of tumor patients are always in dynamic changes
.

A new generation of oral PI3Kδ/CK1-ε dual inhibitor Ukoniq is used to treat patients who have received at least one relapsed or refractory marginal zone lymphoma (MZL) based on an anti-CD20 regimen or who have received at least 3 systemic therapies.
Or refractory follicular lymphoma (FL) adult patients
.

Nexpovio was approved by EMA to be used in combination with dexamethasone to treat at least two proteasome inhibitors (PI), two immunosuppressive agents (IMiD), and one anti-CD38 monoclonal antibody.
Adult patients with refractory, relapsed or refractory multiple myeloma (RRMM) whose disease progressed when receiving the last therapy
.
Jazz Pharmaceuticals’ Rylaze has been approved by the US FDA for the treatment of children and adults aged 1 month and older who are allergic to E.
coli-derived asparaginase
.
Tivdak is used to treat adult patients with recurrent or metastatic cervical cancer who have progressed during chemotherapy or after chemotherapy to deal with the current situation that once cervical cancer recurs or metastasizes, clinical treatment options are very limited
.
Minjuvi is used in combination with lenalidomide and then tafasitamab as a monotherapy for adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/rDLBCL) who are not suitable for autologous stem cell transplantation (ASCT)
.

China's "Guiding Principles of Anti-tumor Drugs" also clearly proposes to always pay attention to the changes in patients' treatment needs, and constantly explore the unmet clinical needs of anti-tumor patients
.

Always pay attention to the changes in the treatment needs of patients, and constantly explore the unmet clinical needs of anti-tumor patients
.

0 4.
Continuously improve drug safety

0 4.
Continuously improve drug safety

Breyanzi was originally developed by Juno as a CAR-T cell therapy targeting CD19 antigen
.
Compared with other CAR-T therapies already on the market, Breyanzi has the best safety data.
The ratio of CD8-positive and CD4-positive T cells is 1:1, which can better control the side effects of cell therapy
.
The FDA-approved Cosela is the world's first and only bone marrow protective therapy that can reduce the incidence of chemotherapy-induced bone marrow suppression, and can provide bone marrow protection for ES-SCLC patients undergoing chemotherapy
.
It can reduce the incidence and duration of severe neutropenia and anemia, and reduce the need for rescue interventions such as growth factors and red blood cell transfusion
.
China’s "Guiding Principles of Anti-tumor Drugs " proposes that in the development of anti-tumor drugs, attention should be paid to the safety of tumor patients, especially the increasing demand and expectations for the safety of long-term drugs, which will increase and continuously improve the anti-tumor drugs Security is an important research direction
.

In the research and development of anti-tumor drugs, attention should be paid to the safety of tumor patients, especially the increasing demand and expectations for the safety of long-term drugs.
Improving and continuously improving the safety of anti-tumor drugs is an important research and development direction
.

0 5.
Improve treatment experience and convenience

0 5.
Improve treatment experience and convenience

In March of this year, the US FDA approved Abecma for the treatment of adult patients with relapsed and refractory multiple myeloma (R/RMM)
.
Abecma is the world's first BCMA-oriented CAR-T cell therapy on the market
.
The approval of Abecma on the market will provide such patients with a new, effective, and personalized treatment plan that can achieve rapid, deep, and lasting relief with only one infusion
.
In addition to the development of long-acting preparations, other improved routes of administration given in China's "Guiding Principles of Anti-tumor Drugs" include the development of subcutaneous preparations and oral preparations to improve the convenience of patient treatment; reduce the frequency of administration and help reduce patient treatment Burden
.

Improve the convenience of treatment for patients; reduce the frequency of administration, which helps reduce the burden of treatment for patients
.

Innovation is a long-term process that cannot be accomplished overnight
.
China's pharmaceutical innovation has a good start, but the road ahead is still long.
What is certain is that the direction of China's vigorous development of innovative drugs is very clear, strengthen the integration of research, industry and academia, fully link the academic and business circles, and open up the source of innovation and commercialization to meet the needs of patients.
As the core, with clinical application as the purpose, to promote the gradual formation and improvement of the industrialization chain
.
The pharmaceutical industry is closely related to people's lives and is an everlasting sunrise industry.
Higher innovation requirements will only accelerate China's progress towards an era of innovation in the pharmaceutical industry and usher in a golden age of pharmaceutical innovation
.