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Introduction
IntroductionIn recent years, driven by technological progress, intensified competition and policy guidance, many large local pharmaceutical companies have joined the
army of innovative drug research and development.
From the sales of generic drugs in the past to the record high number of clinical applications for new drugs in recent years, "innovation transformation" has become an important proposition for the sustainable development of
local pharmaceutical companies.
However, the road to transformation is not easy, and enterprises are moving forward
in twists and turns.
Grasping the pulse of the market and giving full play to their own endowments is the only way
for enterprises to get out of the predicament.
Starting from the current situation and characteristics of the innovation and transformation of local pharmaceutical companies in China, this paper will share the diversified innovation and transformation paths of local pharmaceutical companies, and try to provide ideas
for the innovation and transformation of local pharmaceutical companies.
1 The current situation of innovation and transformation of local pharmaceutical companies in China
1 The current situation of innovation and transformation of local pharmaceutical companies in ChinaFrom the perspective of the number of drugs listed, the innovation and transformation of local pharmaceutical companies has achieved initial results
.
From 2017 to November 2022, a total of 311 innovative drugs were approved for marketing in the Chinese market, including 79 Class 1 new drugs and 232 Class 5 new drugs
.
Since 2018, the number of innovative drugs approved by local pharmaceutical companies has risen
rapidly.
By 2022, the proportion has reached 17%, of which Hengrui ranks first with 8 approved innovative drugs, and Hausen and Hutchison Whampoa rank second and third
respectively.
.
Judging from the number of clinical applications approved, local large pharmaceutical companies are accelerating their transformation
to innovation.
In 2021, the number of IND applications from local leading pharmaceutical companies such as Hengrui, Chia Tai Tianqing, Haosen, and Qilu increased explosively
.
In particular, Hengrui Pharmaceutical, in 2021, 31 INDs were declared, including many FIC/BIC varieties
such as CD112R/TIGIT bispecific antibody and CTGF monoclonal antibody with the world's leading research progress.
to innovation.
However, from the perspective of sales amount, the current contribution of innovative drugs to the revenue of local pharmaceutical companies is still very limited
.
According to the channel sales statistics of IQVIA large hospitals with more than 100 beds, the average contribution of Class 1 new drugs of the top ten local pharmaceutical companies to the channel sales of large hospitals is 16%.
However, if mature products listed before 2017 are excluded, and only innovative drugs listed in 2017 and later are considered, only three of the top ten local pharmaceutical companies account for more than 10% of the sales of innovative drugs
.
.
2 Characteristics of innovation and transformation of local pharmaceutical companies in China
2 Characteristics of innovation and transformation of local pharmaceutical companies in ChinaFeature 1: "combination of generic and innovative", generic drug business provides stable cash flow
for innovative drug research and development.
Unlike start-up pharmaceutical companies that raise funds through the capital market to invest in new drug research and development, most of the R&D funds of large local pharmaceutical companies come from their own generic drug business
.
While taking the research and development of innovative drugs as a strategic focus of enterprises, large pharmaceutical companies have not neglected the hematopoietic capabilities
of "first generic" and "high-end generic drugs".
Even Hengrui, a leading pharmaceutical company in innovation and transformation, was approved 6 "first imitations" in the first half of last year, ranking first in the number of "first
imitations" approved.
In 2021, large local pharmaceutical companies with rich innovative drug pipelines, such as Chia Tai Tianqing, Qilu, and Kelun, all ranked among the top five
in terms of the number of generic drug approvals.
for innovative drug research and development.
Feature 2: The development of "improved new drugs" is a unique innovation method
for large local pharmaceutical companies.
Compared with Biotech, which specializes in Class 1 new drugs, the innovation of local large pharmaceutical companies has another direction in addition to the research and development of Class 1 new drugs: Class 2 improved new drugs
.
In the past three years, the number of registration and acceptance of chemical class 2 new drugs has shown an upward trend, of which class 2.
2 "dosage form improvement" has become the main focus of enterprises
.
"Improved new drugs" have the advantages of
low average investment, short development cycle and low risk.
Many improved new drugs have also shown good commercialization prospects
.
For example, in October 2021, Yizhong Pharmaceutical's Class 2.
2 anti-tumor new drug "paclitaxel polymer micelles" was approved for marketing
.
Compared to albumin paclitaxel 33%.
ORR (Overall Objective Response Rate), the ORR of the former reaches 50%.
While avoiding short-term centralized procurement risks, the current market size of the latter also brings considerable market potential space
to the new generation of drugs.
for large local pharmaceutical companies.
Feature 3: The innovation path of large local pharmaceutical companies is diversified, and diversified cooperation models such as independent research and development, license-in, mergers and acquisitions and strategic cooperation are constantly emerging
.
Leading local enterprises have built a more comprehensive independent R&D platform, such as Hengrui has more than 5,000 R&D technicians, and a number of approved Class 1 new drugs, such as apatinib, fluzoparib, reverutamide, etc.
are all independent research and development products
.
Another example is that Kelun Pharmaceutical has built a relatively complete ADC R&D platform and system, and a number of ADC products have entered the clinical and pipeline stage
.
Compared with local large pharmaceutical companies with more complete R&D systems, many local pharmaceutical companies have also chosen to accelerate their transformation through license-in, incubation, acquisition of overseas R&D platforms, etc.
, such as CSPC Pharmaceutical's acquisition and establishment of a number of macromolecular R&D platforms in the United States since 2017, among which a Claudin18.
2 monoclonal antibody under the NovaRock platform reached a license-out agreement with FlameBiosciences in 2021 to achieve overseas authorization
。
.
3 Case study of innovation and transformation of local pharmaceutical companies in China
3 Case study of innovation and transformation of local pharmaceutical companies in China(1) Stone medicine: independent research and development plus external introduction to achieve multi-field layout
(1) Stone medicine: independent research and development plus external introduction to achieve multi-field layoutCSPC is the first echelon of large local pharmaceutical companies, and the preparation business provides sufficient cash flow
.
In recent years, CSPC has continuously increased its investment in the research and development of innovative drugs, reaching 3.
3 billion yuan
in 2021.
At present, Shiyao has more than 2000
People's R&D team, in small molecule targeting, nano, monoclonal antibody, dual antibody, ADC, mRNA
Vaccines, oligonucleotide drugs, site-specific conjugated modified polypeptides, proteins and immunity and other fields have been deployed
.
In addition to internal self-research, CSPC has also filled the development gap in the fields of neurology, oncology, cardiovascular, nephrology, ophthalmology and other fields through the BD team, and has a number of popular technology development platforms
such as ADC and bispecific antibodies through self-construction and acquisition.
At present, there are more than 100 pipelines under research of CSPC, and a number of innovative drug products are about to usher in the harvest period
.
(2) Kelun Pharmaceutical: focuses on the layout of ADC, and the self-developed pipeline has been recognized by international leading pharmaceutical companies
(2) Kelun Pharmaceutical: focuses on the layout of ADC, and the self-developed pipeline has been recognized by international leading pharmaceutical companiesKelun Pharmaceutical is the largest infusion manufacturer
in China.
In 2012, Kelun established the research institute, starting from the rapid start of generics, and started the research of more than 300 drugs, and the R&D investment and the number of R&D personnel continued to increase
.
In terms of macromolecules, Kelun has built its own ADC R&D platform and complete R&D system to develop BIC drugs
for mature targets.
In terms of small molecules, Kelun selects low-risk mature targets for independent research and development to achieve a wide range of disease field layout
.
By the end of 2021, Kelun's R&D pipeline contained 25 innovative small molecule drugs and 30 biological macromolecule drugs
.
It is mainly tumor-based, and at the same time lays out the fields of liver disease, cardiovascular, anesthesia and analgesia, autoimmunity, etc.
, forming disease clusters and product iteration advantages
.
In 2022, two pipeline ADC drugs of Collun reached exclusive licensing cooperation research and development agreements
with Merck.
(3) Lizhu Pharmaceutical: Microspheres plus biopharmaceutical dual platform to build a competitive moat
(3) Lizhu Pharmaceutical: Microspheres plus biopharmaceutical dual platform to build a competitive moatLizhu Pharma started as antibiotics and digestive drugs.
In 2010, it entered the stage of innovation and transformation, focusing on two major sectors
: biological drugs and microsphere preparations.
In terms of biological drugs, Lizhumab and Lizhu Biotech subsidiaries were established, focusing on oncology, immunological diseases and assisted reproduction
.
There are 7 research projects, and the key varieties of recombinant human chorionic gonadotropin have been marketed, and tocilizumab biosimilars have entered the production stage and are about to enter the harvest period
.
In terms of microsphere preparations, the therapeutic field focuses on the advantages of assisted reproduction and digestive tract, strengthens psychiatric and tumor immunity, and has 7 research projects
.
Lizhu began to develop a research and development platform for microsphere preparations in 2013 due to high technical
barriers.
At present, only three domestic enterprises, including Lizhu, have microsphere products on the market, with a good competitive pattern, fast research and development speed, low risk, and is expected to bring considerable returns
.
(4) Sihuan Pharmaceutical: The performance of medical cosmetology continues to be released, and the milestone of innovative drugs is fulfilled
(4) Sihuan Pharmaceutical: The performance of medical cosmetology continues to be released, and the milestone of innovative drugs is fulfilledSihuan Pharmaceutical is a domestic pharmaceutical enterprise in the field of cardiovascular and cerebrovascular characteristics, which started the journey of innovation and transformation in 2012, focusing on the cardiovascular and oncology fields, with more than 30 innovative drug pipelines, of which 5 products will be approved for marketing
soon.
On the road of innovation and transformation, in addition to the layout of innovative drugs, Sihuan Pharmaceutical has also set its sights on the "small but beautiful" medical beauty market
.
Since signing an agency agreement with Hugel for botulinum toxin and hyaluronic acid products in 2014, Sihuan Pharmaceutical has opened a comprehensive layout
in the field of medical cosmetology.
In 2020, South Korea's botulinum toxin product Letibao was launched in China and officially sold by Sihuan Pharmaceutical's exclusive agent, and in 2021, its self-developed medical beauty product Tong Yan Shui Gel was launched
.
In 2021, the sales revenue of the company's medical beauty products achieved rapid growth, reaching 400 million yuan
.
At present, innovative drugs and medical cosmetology have become the core business
of Sihuan Pharmaceutical.
4 Conclusion and outlook
4 Conclusion and outlookIn the past decade, large local pharmaceutical companies have benefited from the continuous expansion of the market and policy support and encouragement, and have been able to develop rapidly, firmly occupying more than 70% of
China's pharmaceutical market.
As multinational pharmaceutical companies and emerging pharmaceutical companies continue to increase their investment in innovation and R&D, and policies are favorable to high-quality innovative products, the pain points of weak R&D strength of local pharmaceutical companies are gradually emerging
.
How to improve innovation capabilities has become one of the core propositions of the transformation of
large local pharmaceutical companies.
Innovation R&D capability is the first element
of innovation transformation.
Different companies have different capital scales, R&D strengths, and therapeutic areas, and have different
R&D layouts.
Choose hot tracks such as oncology, self-exemption or "small and beautiful" potential markets, through independent research and development or the introduction of external high-quality assets, "wide net" layout or specialization in a certain field, strive for FIC/BIC or choose preparation innovation or similar improvement, different pharmaceutical companies give different answers, but "differentiated research and development" and "patient benefits and clinical value to guide research and development" has become a consensus
.
Local pharmaceutical companies should differentiate their layout by deploying new targets, iterative R&D technologies, and changing development strategies, and pay attention to unmet clinical needs, avoid homogeneous competition, and improve the clinical value of innovative drug development and patient benefits
.
After the successful development of innovative drugs, commercialization is another challenge facing pharmaceutical companies, and local pharmaceutical companies should pay attention to the "diversification"
of payment and channels.
On the payment side, local pharmaceutical companies can actively try different payment methods such as national medical insurance, Huimin insurance, and commercial health insurance to build a diversified and multi-level payment system
.
In terms of channel diversification, local pharmaceutical companies should deploy channels according to the nature of their products, and actively explore retail market opportunities such as DTP pharmacies outside the traditional hospital channels.
At the same time, more and more Chinese local pharmaceutical companies have begun to try to expand overseas market opportunities, and carry out innovative drug "going overseas"
through "license-out" or building their own overseas sales teams.
In the next ten years, China's pharmaceutical industry will continue to upgrade, the concentration of market leading enterprises will further increase, the proportion of generic drugs will decline, and the industry will move from "pan-innovation 1.
0" to "high-quality innovation 2.
0"
.
Local large pharmaceutical companies should seek "opportunities" in the "crisis", take advantage of existing channels, supply chains and cost advantages, choose appropriate innovation and transformation paths, achieve "fast, ruthless and accurate" business breakthroughs, and promote the sustainable development of
enterprises.
