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Zhang Lianshan: Innovation is everywhere, don't worry about being compared with others｜Jianghu

 Last Update: 2022-02-20
 Source: Internet
 Author: User

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Dr.
Zhang Lianshan believes that traditional pharmaceutical companies need more adventurous spirit, explore new targets, and take higher R&D risks
.

At the first Suzhou Yihong Forum held by Yihong Business School of Shenyang Pharmaceutical University, I met Dr.
Zhang Lianshan, President of Global R&D of Hengrui Medicine
.

Zhang Lianshan, who has a Ph.
D.
background in organic chemistry, joined Marcadia Biotech, a biotechnology company, in 2008 to focus on metabolic disease research after working in Eli Lilly for ten years
.

Since joining Hengrui Medicine in 2010, he has witnessed the remarkable development of China's pharmaceutical industry from imitation to innovation, and the Hengrui Medicine R&D team he leads is a witness to this change

The exclusive interview with Dr.
Zhang Lianshan was completed in the company of Ms.
Zhang Xianglin, the founder and honorary dean of Yihong Business School
.

Dean Zhang also respected Dr.

Dr.
Zhang Lianshan

"Innovation should be understood differently according to different historical stages of China's pharmaceutical industry
.

" Dr.

"Innovation must solve the health problems of patients.

For enterprises, it is a systematic and systematic design and plan, from the establishment of a variety project to marketing promotion, from strategy to implementation, from high-level decision makers to the collective battle of the whole team

Dr.

Zhang Lianshan opened up the conversation on the topic of innovation and the transformation of traditional pharmaceutical companies

Q&A: Focus on yourself

R&D customer: What is the most difficult thing about the innovation and transformation of traditional pharmaceutical companies?

Zhang Lianshan: For traditional pharmaceutical companies, we have no basis for innovation, and we need to make up our minds to change systems and concepts and invest real money in research and development
.

We are a traditional enterprise that invests every cent of our sales revenue into drug research and development, while taking into account the employment and family of the generic drug research and development team, relying on complete self-reliance

Zhang Lianshan:

The R&D and commercialization of innovative drugs cannot be accomplished overnight, and companies will go through a difficult transition period.
This is a long-lasting process that requires time and patience
.

However, I firmly believe that the innovation environment is getting better and better, and there will be more and more traditional pharmaceutical companies that have successfully transformed like Hengrui

R&D customers: Hengrui Pharmaceutical ranks 38th in the 2021 Top 50 Global Pharmaceutical Companies of the American "Pharmaceutical Manager" (PharmExec)
.

In your opinion, how long will it take for Chinese pharmaceutical companies to enter the world's top ten?

R&D customers: Hengrui Pharmaceutical ranks 38th in the 2021 Top 50 Global Pharmaceutical Companies of the American "Pharmaceutical Manager" (PharmExec)
.
In your opinion, how long will it take for Chinese pharmaceutical companies to enter the world's top ten?

Zhang Lianshan: To be honest, I don’t know much about these rankings, and I focus more on my own development, but I sincerely thank domestic and international counterparts for their recognition of Hengrui
.
After all, China's pharmaceutical industry is not in the same rank compared with European and American big pharmaceutical companies, and our industry concentration is still relatively low.
We may be able to benchmark against Johnson & Johnson, Roche and Novartis
.
Fortunately, China's new drug R&D contribution rate has entered the second echelon in the world
.
Hengrui hopes to unite the best basic research and clinical development resources in the country, cooperate with talents and innovative companies with the most innovative thinking and experience, and move towards the goal of the top ten pharmaceutical companies in the world
.

Zhang Lianshan:

R&D guest: What do you think of the hot words "involution", "getting together" and "buy and change" some time ago?

Zhang Lianshan: Only a person who has truly innovated can know the ups and downs in the innovation process
.
Innovation is ubiquitous in the entire ecological chain.
We don’t have to always struggle with this matter, and don’t always start to worry when comparing with others, focus on ourselves, and solve the needs of patients
.

Zhang Lianshan:

R&D Customer: What are the principles you uphold in your work? What is the biggest motivation for your work?

Zhang Lianshan: Hengrui recently made a promotional video for cancer drug patients participating in drug clinical trials.
The voices of those subjects touched me very much and gave me the greatest motivation to work
.
I have lived my life to make medicine
.
Whenever I see that those critically ill cancer patients are reborn or improve their quality of life because of our products, I am moved and feel that my work is of extraordinary significance
.

Zhang Lianshan:

How did Hengrui transform?

In recent years, the domestic pharmaceutical ecological environment has undergone tremendous changes, and a series of reform policies have encouraged innovation
.
Overseas new drugs are being launched at an accelerated pace, and the Chinese market for foreign companies continues to expand
.
At the same time, domestic biotech companies have risen rapidly
.
In the past 10 years, the total investment and financing in the biopharmaceutical field has reached nearly 200 billion yuan.
In the past 10 years, more than 1,500 biotech companies have been established in the Chinese pharmaceutical industry
.
They have gradually matured from early discovery to commercialization, from independent research and development to product introduction and external authorization
.

Under the heavy pressure of centralized procurement and medical insurance negotiations, traditional generic drug companies are shrinking in business and facing multiple attacks, and the transformation strategy is already on the line
.

Hengrui Medicine has carried out strategic deployment very early, transforming from "sales-oriented" to "R&D-oriented", and has achieved remarkable results since its development
.
According to the third quarterly report of Hengrui Medicine in 2021, during the reporting period, the operating income in the three quarters was 20.
199 billion yuan; the net profit was 4.
207 billion yuan
.
In the secondary market, Hengrui Medicine once reached the highest price of 97.
16 yuan per share in 2021, with a total market value of over 600 billion yuan, and is in the "first echelon" position in China's pharmaceutical innovation
.
Dr.
Zhang Lianshan said this was thanks to five strategies
.

Strategy 1: Strengthen independent research and development and adjust the layout of research and development
.
Traditional large pharmaceutical companies such as Hengrui Medicine and Xinlitai have adjusted the general direction of research and development, stopped the development of low-end generic drugs, and focused on the research and development of innovative drugs
.
Among them, R&D investment is a major test
.
According to the third quarterly report of Hengrui Medicine in 2021, the research and development investment of Hengrui Medicine in the first three quarters of 2021 will reach 4.
14 billion yuan, a year-on-year increase of 23.
9%, accounting for 20.
5% of revenue
.
It has become one of the largest pharmaceutical companies in China that attaches great importance to R&D investment
.

Strategy 1: Strengthen independent research and development and adjust the layout of research and development
.

Hengrui Medicine's redefinition of innovation and internationalization

The second strategy is to introduce projects and rapidly expand the product pipeline
.
Since the beginning of this year, Hengrui Medicine has rapidly introduced domestic and foreign projects, expanded pipelines and realized commercialization of at least 4 cooperation projects, all of which are innovative drugs (mainly biological drugs) that are progressing rapidly in the same category
.

The second strategy is to introduce projects and rapidly expand the product pipeline
.

On November 21 last year, Hengrui introduced Cornerstone's anti-CTLA-4 mAb CS1002 injection with a down payment of 52 million yuan and a milestone payment of about 1.
185 billion yuan
.
Hengrui’s other imported projects include Tianguangshi’s MIL62, which is the first domestically produced third-generation CD20 monoclonal antibody to enter Phase III clinical trials.
The domestic drug with the same target is Roche’s ortuzumab (global sales in 2020).
632 million Swiss francs); and Yingli Pharmaceutical's YY-20394, which is the first domestic PI3kδ inhibitor to submit a marketing application, and no domestic drug with the same target has been approved yet
.

Strategy three, cooperative development to achieve a win-win situation
.
Although Hengrui Medicine has full industrial functions from R&D, production to sales, their external cooperation is still very open, including cooperative development with pharmaceutical companies and cooperation with CDMOs
.
"Previously, we concentrated on independent research and development, and now we have changed our thinking, and achieved win-win faster with the help of cooperative development and joint development
.
" Dr.
Zhang Lianshan said
.

Strategy three, cooperative development to achieve a win-win situation
.

Strategy 4: Acquire new companies and quickly enter the innovative drug track
.
Zhang Lianshan said with a smile: "This is the icing on the cake and the way to seize the position.
It is not ruled out that Hengrui will merge and acquire companies with complementary products under development at home and abroad and similar corporate cultures in the future, regardless of size
.
"

Strategy 4: Acquire new companies and quickly enter the innovative drug track
.

Strategy 5: Set up subsidiaries to focus on the research and development of innovative drugs
.
For example, Ruishi Pharmaceutical, a subsidiary of Hengrui, has continuously released innovative products and carried out international multi-center clinical research
.

Strategy 5: Set up subsidiaries to focus on the research and development of innovative drugs
.

Traditional pharmaceutical companies need more adventurous spirit

Zhang Lianshan believes that traditional pharmaceutical companies need more adventurous spirit, explore new targets, and take higher R&D risks
.

From the perspective of therapeutic targets, Hengrui Medicine has deployed global popular targets and cutting-edge therapies, such as PD-1/PD-L1, BTK, CDK4/6, JAK,
etc.
A number of drugs with the same target have not been approved at home and abroad, including fully human OX40 monoclonal antibody, Toll-like receptor immune agonist, selective FXIA inhibitor, A2aR inhibitor, ROMK inhibitor, LAG-3 antibody, TIM-3 monoclonal antibody,
etc.

Since the "Clinical Value-Oriented Guiding Principles for Clinical R&D of Antitumor Drugs" proposed that new drug R&D should provide better (more effective, safer or more convenient) treatment methods, the entire R&D industry has turned to developing drugs based on clinical needs.

.
Hengrui Medicine is also fully exploring the potential of research targets in various indications and exploring new indications
.

Take the JAK1 inhibitor SHR0302 as an example.
SHR0302 is a highly selective JAK1 inhibitor developed by Ruishi Biopharmaceuticals, a subsidiary of Hengrui.
Clinical trials are carried out in various indications such as psoriatic arthritis
.
On January 26, 2021, the drug was included in the CDE's Breakthrough Therapy Drug Program for the treatment of moderate-to-severe atopic dermatitis in adolescents and adults 12 years of age and older
.

From the perspective of therapeutic areas, Hengrui has deployed a number of therapeutic areas, with 108 innovative drugs (81 category 1 new drugs) involving more than ten therapeutic categories, covering multiple diseases and multiple organs, focusing on anti-tumor, nervous system, digestive system and other therapeutic areas, of which anti-tumor drugs account for nearly "half of the country", covering lung cancer, breast cancer, liver cancer, gastric cancer and other diseases
.

Hengrui Medicine involves drugs at different stages of research and development in five major disease areas

In the field of tumor immunotherapy, Hengrui Medicine focuses on the development of tumor-related macrophages, Treg cells, dendritic cells, cytotoxic T cells, NK cells, and corresponding target drugs in the tumor microenvironment, and has new drugs under development.
clinical trials
.

The research direction of Hengrui Medicine's tumor immunotherapy

In order to continuously generate independent research and development projects with global rights and interests, Hengrui Medicine also develops new technology platforms, self-developed ADC drugs, develops double antibody/poly antibody, and deploys siRNA, mRNA and gene therapy in nucleic acid drugs
.

Hengrui Pharmaceutical Technology Platform for Chemical Drugs, Biological Drugs and Nucleic Acid Drugs

Hengrui Medicine has a rich R&D pipeline.
According to statistics from Minet.
com, from 2020 to the third quarter of 2021, a total of 36 new drugs for IND new molecules have entered clinical trials, 13 of which are INDs for oncology drugs and 23 for non-tumor drugs; At the end of the year, more than 30 new drug clinical trial applications were submitted
.
In terms of marketing applications, from 2020 to the third quarter of 2021, a total of 12 new indications were approved, and more than 15 new indications are planned to be submitted by next year
.

Hengrui Medicine's 2020~2022 IND and NDA filing plan

In order to go international, Hengrui has established R&D centers or branches in the United States, Europe, Japan and China, and has built a R&D team of more than 4,700 people around the world
.
Zhang Lianshan proudly said that the strength of Hengrui's overseas team lies in scientific communication with various regulatory agencies in the framework of ICH, and at the same time establishing good cooperation with researchers in research centers in Europe and the United States
.
Especially in the R&D center in Japan, focusing on the registration application, sub-packaging and sales of high-end preparations is a good channel for the future development of Hengrui Medicine
.

R&D centers established by Hengrui around the world

Hengrui Medicine has successfully transformed from imitation to innovation, and also completed the construction of the innovation system emphasized by Dr.
Zhang Lianshan at the beginning
.

Highways and dirt roads

The interview is naturally inseparable from the topic of medical insurance negotiation
.
Hengrui's 3 Class 1 new drugs approved after 2020 participated in the national medical insurance negotiation in 2021, and all of them were successfully selected
.
Up to now, the group has entered the National Medical Insurance List for a total of 85 drugs, including 8 innovative drugs that have been approved for marketing
.

Finally, he used an image metaphor.
The market return is the reflection of the value of innovation.
The research and development of new drugs must be connected by "highways" (return and payment of innovative drugs).
price), which would obviously make this fast lane moot
.
He sincerely hopes that the national medical insurance department can give more understanding and support to the hard-won innovation
.

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