Analysis of the layout of Chinese innovative drugs at home and abroad: Do not all innovative drugs have a future?

1.
Industry perceptions in a few words

1.
Industry perceptions in a few words

Recently, there has been a saying in the pharmaceutical industry: not all innovative drugs have a future
.

Seeing this statement, I remembered the lyrics-Wild Lily also has spring

Is it because of such a high failure rate that this industry will be regarded as a daunting task? We are delighted to see that after more than ten years of struggle and tempering, the participating teams in China’s innovative drug industry, whether they are developers, investors, or regulators, have prepared for this situation and promoted it.
Many projects have been successful, or are on the road to success
.

2.
Analysis of the overall situation of China's pharmaceutical industry

2.
Analysis of the overall situation of China's pharmaceutical industry

On October 8, 2021, Evive Biotech, a holding subsidiary of Evive Biotech, announced that the European Medicines Agency (EMA) has officially accepted Evive Ryzneuta™ for the treatment of chemotherapy-induced neutropenia (CIN).
)’S marketing authorization application (MAA), and a centralized review process has been initiated
.

This is also another good news after Yiyi Biotech submitted the Ryzneuta™ (also known as F-627) Biological Products License (BLA) to the FDA in early 2021

For a long time, the current situation of drug R&D in China has been worrying, which is mainly manifested in the insufficient investment in R&D of enterprises; and in some areas, there is waste of R&D resources and low efficiency; the homogeneity of drug R&D projects is serious, and the competition with target development is fierce, which can be described as involuntary Energetic; pharmaceutical companies are not innovating enough, and the level of innovation is not enough
.

In recent years, the domestic pharmaceutical market has continued to mature and improve.

3.
Domestic policy support and results

3.
Domestic policy support and results

In 2015, the State Council issued the "Opinions on Reforming the Review and Approval System for Drugs and Medical Devices"; in February 2016, the State Food and Drug Administration issued the "Opinions on Resolving the Backlog of Drug Registration Applications and Prioritized Review and Approval"; in 2017, the Central Committee of the Communist Party of China The General Office and the General Office of the State Council issued the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices".
The development of pharmaceutical innovation
.

In 2016, the General Office of the State Council issued the "Pilot Plan for the Drug Marketing Authorization Holder System", which is of great significance for encouraging drug innovation and improving drug quality
.

In 2018, the National Medical Security Administration included 17 anti-cancer drugs into the category B scope of the national basic medical insurance, work-related injury insurance and maternity insurance drug catalogs, opening up a path for innovative drugs to enter the medical insurance catalog through negotiations
.

In 2019, the newly revised Drug Administration Law was formally implemented, which also clearly stipulates that the state encourages research and creation of new drugs
.

In 2020, with the outbreak of the new crown epidemic, some drug research and development and review work have been affected
.

However, this kind of epidemic pressure has provided a rare opportunity in history for the development of new crown prevention and treatment drugs

From 2020 to 2021, China's NMPA has continuously updated and revised many guiding principles in order to cope with the implementation and implementation of the 2019 revision of the Drug Administration Law
.

In October 2021, China's drug application requirements for the eCTD format are also officially implemented
.

After the National Day in 2021, the call for pre-BE filing in drug research and development has been actively responded to by NMPA, and the introduction and update of policies in this field will also be promoted
.

In recent years, the number of domestic innovative new drug applications and approvals has continued to increase.
According to incomplete statistics, NMPA has approved 10 domestic innovative drugs in 2020, and NMPA has approved 11 domestic innovative drugs since 2021 (as of September 2021 ) (See Table 1 for details)

Table 1 Domestic innovative drugs approved by NMPA in the past two years

Analysis: From the above statistics, it can be seen that at present, innovative drug companies and successful projects are mostly located in the Yangtze River Delta and traditionally advantageous regions, such as Shandong Province
.

The field of drug therapy focuses on the treatment of cardiovascular diseases

4.
Innovative domestic innovative drugs go overseas and go global

4.
Innovative domestic innovative drugs go overseas and go global

As China's innovative drug companies continue to grow stronger, many leading companies have begun to actively explore the international market and have achieved gratifying results
.

The following is a brief summary of the development of innovative drugs in the international market in the past period of time:

On November 15, 2019, a milestone event in China's new drug development: BeiGene's self-developed anti-cancer drug "Zebutinib" was approved for listing by the US FDA, and Zebutinib became the first approved listing in the United States China's independent research and development of drugs
.

In September 2021, the US FDA approved the second indication of Baiyueze (Zebutinib) for the treatment of patients with Waldenstrom's macroglobulinemia

On December 20, 2019, CSPC announced that the FDA has approved the marketing application (NDA) of Conjupri (levamlodipine maleate) tablets for the treatment of hypertension
.

In July 2020, Trastuzumab (HLX02, EU trade name: Zercepac) independently developed by Henlius was approved for listing in the EU
.

In May 2019, Luye Pharmaceutical submitted a marketing application for Risperidone Microspheres II for injection to the US FDA
.

In November 2020, Biotech Biopharmaceuticals announced that it had submitted a biological product marketing application (BLA) for BAT1706 (bevacizumab) injection to the U.
S.
Food and Drug Administration (FDA)
.

Prior to this, the company had submitted an application for BAT1706's marketing authorization to EMA

In December 2020, Hutchison Pharmaceuticals submitted a rolling new drug application (NDA) for Sofatinib for the treatment of pancreatic and non-pancreatic neuroendocrine tumors (NET) to the US FDA
.

In December 2020, Janssen/Legendary Bio announced the beginning of rolling submission of cilta-cel biologics license application (BLA) to the FDA for the treatment of relapsed and/or refractory multiple myeloma in adults
.

In March 2021, Yifan Biopharmaceuticals, a subsidiary of Yifan Pharmaceuticals, submitted a biological product license application (BLA) for Ryzneuta to the FDA for the treatment of chemotherapy-induced neutropenia
.

In March 2021, Junshi Biotech announced that it would begin rolling submission of teriprizumab to the US FDA for the treatment of BLA for recurrent or metastatic nasopharyngeal carcinoma
.

In April 2021, Wanchun Pharmaceutical announced that its pranabulin has submitted a new drug application for CIN to CDE and FDA
.

On May 18, 2021, Cinda Bio announced that Sintilimab, jointly developed by the company and Eli Lilly, has been officially accepted by the US FDA
.

In September 2021, BeiGene announced that its self-developed PD-1 monoclonal antibody Bezean (generic name: tislelizumab injection) was approved by the U.
S.
Food and Drug Administration (FDA).
) Formally accepted
.

On October 8, 2021, Evive Biotech, a holding subsidiary of Evive Biotech, announced that the European Medicines Agency (EMA) has officially accepted Evive Ryzneuta™ for the treatment of chemotherapy-induced neutropenia (CIN).
)’S marketing authorization application (MAA), and a centralized review process has been initiated
.

Five, summary

Five, summary

It can be seen from the above data and information that although the high failure characteristics in the field of innovative drugs still exist
.

However, with the overall migration of the international drug R&D field, Chinese innovative drug companies seized the opportunity to continuously develop and rise in attracting funds, recruiting leading talents, building and improving teams, and rationally arranging product lines
.
At present, the dominant projects of China's leading innovative drug companies have been deployed in the domestic and international markets at the beginning of the project.
Most of the project-level projects are implemented in accordance with the ICH guidelines and are actively in line with international regulatory requirements
.

At the same time, we must also remember the reminder at the beginning of the article-not all innovative drugs have a future! In order to avoid the repeated occurrence of such lessons, innovative drug companies still have a lot of work to do in terms of patent layout, equity layout, perfect internal management structure, strengthened R&D team stability, and strengthened learning of international regulations
.

Reference materials:

1- Analysis of China's Encouraging Policies for the Creation of New Drugs in the New Era

2-NMPA official website

3-FDA official website information

4-EMA official website information