The incidence of cancer continues to grow, and there are some new trends in the field of cancer treatment in China

《Managing China’s growing oncology burden》，Tina Hou, Franck Le Deu, Yi Shao, and Jody Tian，。

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In China, the acceleration of innovation in the field of oncology treatment is critical to managing the burden of oncology in China and ensuring that patients receive improved treatment options that ensure patient access and fairness, and these solutions are all transformations in the local environment.
Achieved in the context of ecosystem shaping initiatives.
The current latest trends are driving progress in China's oncology innovation, including the emergence of a wave of new biotechnology companies focusing on the field of oncology treatment and improving the quality of oncology research.
In order to establish a successful cancer treatment business in China, we have identified six key success factors for biopharmaceutical and biotech companies to consider when planning their business strategies.
After outlining the key trends and the medical ecosystems that are changing in them, we introduce these success factors.

(1) Innovative practice in the field of cancer treatment in China

(1) Innovative practice in the field of cancer treatment in China

Due to the following five trends, China is making rapid progress in achieving its oncology R&D goals: a wave of new biotechnology companies, a group of investment portfolios focused on R&D, a focus on immuno-oncology, leadership in cell therapy, and The pursuit of improving the quality of research.

1.
Many new biotech companies have been established

1.
Many new biotech companies have been established

The huge burden of cancer in China, the innovation ecosystem reform supported by the National Medical Products Administration (NMPA), and the opening of Hong Kong’s capital market to pre-income companies have jointly created a good environment for start-ups.
In recent years, a new wave has been set off.
There is a wave of Chinese biotech companies.

Although these Chinese biotech companies usually start through licensing programs developed in North America or Europe, they have innovative ambitions and are particularly active in the field of oncology.
The IPO activities since the end of 2017 have proved this: about two-thirds of all listed companies are focused on the oncology field (Figure 2).
They joined a field already occupied by well-known biopharmaceutical multinational companies, which listed China as a major market for R&D and business activities.
Together, local and multinational companies (MNCs) have shaped a uniquely competitive and innovative oncology business environment.

Figure 2 A considerable number of biotech companies in China are focused on the field of oncology

2.
Concentrated R&D project portfolio

2.
Concentrated R&D project portfolio

In general, both multinational pharmaceutical companies and local companies are focusing on tumor types with a high prevalence in China (Figure 3).
Of the 393 projects being developed by the Chinese biopharmaceutical industry, 60% focus on cancer types, which represent the top five cancers with incidence: lung cancer, colorectal cancer, gastric cancer, liver cancer and breast cancer.
[6]

Figure 3 Multinational companies and local companies generally focus on tumor types with high prevalence or proven successful treatment

In addition, the related tumor types that are successfully treated are still a priority area for pharmaceutical companies.
For example, 84 (21%) of the projects being developed by local biopharmaceutical companies and 19 (5%) of the projects being developed by multinational companies are for lymphoma, which is the second most common disease in China after lung cancer The targeted tumor type, although the incidence rate ranks tenth in the world.

In terms of the number of targets in the clinical development stage, China's level of innovation lags behind that of the United States.
Currently, clinical trials in the United States cover 550 targets, while China has only 160.
The concentration of the US market is also less than that of China.
For example, in the United States, 70% of clinical projects are concentrated on the top 30% of the target, while in China, 70% of clinical projects are concentrated on the top 21% of the target (Exhibit 4).

Figure 4 Clinical trials in China are more focused on major targets than trials in the United States

Taking into account the highly concentrated research and development space for specific cancer types and drug targets, accelerating time to market and differentiation strategies are crucial for multinational and local companies to win in the highly competitive Chinese tumor treatment market.

3.
More and more trials apply immuno-oncology

3.
More and more trials apply immuno-oncology

In recent years, the number of immuno-oncology trials in China has increased rapidly.
In 2015, only four immuno-oncology trials were launched, accounting for 3% of the total number of new trials in China that year.
The number of clinical trials increased to more than 100 again in 2018 and 2019.
As a result, immuno-oncology accounted for a quarter of the oncology trials initiated in China in the past two years.
More local biotech companies are expanding their immuno-oncology product portfolio through self-developed projects and partnerships.
In the United States, 57% of the top five PD-(L)1 drug combination trials are progressing under partnerships (Exhibit 5).
In contrast, in China, many local companies still rely mainly on internal projects.
For example, a company has more than 40 immuno-oncology joint trials, which are 100% self-developed and no partners participate.
Looking to the future, it is vital for biopharmaceutical and biotech companies to explore external partnerships for the immuno-oncology portfolio outside of internal projects so that they can accelerate development and expand indication coverage.

Figure 5 Local biotechnology companies are expanding their immuno-oncology treatment product portfolio through their own developed projects and partnerships

4.
China is a global leader in cell therapy

4.
China is a global leader in cell therapy

China is very active in cell therapy clinical trials and is becoming a global leader.
In China, the development of cell therapy is largely driven by projects initiated by academia and hospitals: in the 84 CAR-T trials initiated in the 12 months from May 2019 to April 2020, [7 ] 89% belong to this field (Exhibit 6).
Like tumor immunity, cell therapy will become a highly competitive market.
High-quality manufacturing capabilities and competitive price programs will be important requirements for the commercial success of cell therapy in China.

Figure 6 In China, academia/hospital-sponsored programs contributed half of CAR T cell therapy trials, and only a small portion was used for drug registration

5.
The quality of research is improving

5.
The quality of research is improving

Although China's leading researchers (PIs) are still under-represented globally, the improvement in the quality of Chinese cancer research has been recognized.
The number of Chinese PI oncology articles published in the top five journals has grown at a rate of 24% per year, from 20 in 2015 to 47 in 2019.
[8] The number of Chinese PIs giving oral presentations at the American Society of Clinical Oncology (ASCO) meetings has also increased, with the number of PIs increasing from one in 2015 to six in 2019.
However, China’s PI still only accounts for 2% of all speakers at ASCO meetings.
[9] Biopharmaceutical and biotechnology companies should strengthen their contacts with Chinese PIs and provide them with more opportunities to lead global programs and innovative research.

(2) The transformation and shaping of the ecosystem will improve cancer treatment in China

(2) The transformation and shaping of the ecosystem will improve cancer treatment in China

Although patients’ access to quality care is improving, basic gaps still exist.
The three main obstacles are late diagnosis, low biomarker detection rates and different quality of treatment.

In China, most patients are still diagnosed with advanced disease (stage III or IV), with limited opportunities for early screening.
For example, the latest diagnosis rate of non-small cell lung cancer is as high as 80%.
[10] Local governments and pharmaceutical companies are studying early screening programs for certain cancers.
The colorectal cancer screening program in Shanghai has increased the early diagnosis rate to 53% (among all diagnosed patients), a four-fold increase over previous years.

Cancer biomarkers have increased the success rate of tumor treatment, but the adoption rate of cancer biomarker testing varies among different hospital levels in China.
Experts tell us that in the top 500 hospitals, the detection rate of key biomarkers such as EGFR and HER2 can reach 80% to 95%.
However, due to high costs and limited availability, the rate of next-generation sequencing tests is only 15%.
Different hospital categories have different treatment capacities, capabilities and standards, and the proliferation of available treatment options complicates the situation.

The cancer care ecosystem is constantly evolving to support improved patient access.
A number of stakeholders, including pharmaceutical companies, hospitals, diagnostic and imaging companies, and direct-to-patient (DTP) pharmacies, have established the cancer care "Ecosystem 1.
0" on a large scale.
The Center of Excellence (CoE) is an example of the output of these broad stakeholders.
These centers aim to improve the prognosis of patients by providing patients with one-stop services (such as consultation, laboratory testing and imaging, pathological examination and treatment).

Looking to the future, more stakeholders including artificial intelligence (AI) and digital companies, real evidence data integrators, and private insurance companies are working together to create a more advanced "Ecosystem 2.
0".
The core of this new Ecosystem 2.
0 is the use of data and analysis.
For example, the use of AI in medical imaging is expected to help the diagnosis of different cancers and clinical decision-making for risk stratification, which can help improve the (early) diagnosis of diseases, especially in lower-level hospitals.
[11] The diagnosis of pulmonary nodules and melanomas related to AI solutions is likely to be the first or second wave of innovations, and these innovations will receive a Class III medical device certificate in China.

The policy's east wind has promoted attention to China's real-world evidence.
For example, according to the real evidence generated in China, the indications of Avastin in 2019 have been expanded to non-small cell lung cancer.
The Chinese government has been working hard to develop a regulatory framework to guide the development of local real-world evidence, and issued the first indicative guidelines in January 2020.
Although challenges remain, including poor data quality and lack of data standards due to the fragmented electronic medical record system, it is expected that more practical evidence will emerge in the pharmaceutical value chain.

In addition, private medical insurance companies are actively shaping the cancer care ecosystem by providing affordable insurance products to the general public.
For example, WeSure provides a monthly tumor insurance of six yuan through the WeChat platform; within three years after the first diagnosis, it covers all anti-tumor drugs on the market, with an upper limit of 3 million yuan.
Although commercial health insurance (CHI) is in its infancy, it is expected to play a greater role in improving patients' access to oncology drugs.

With the expansion of the cancer care ecosystem, it is expected that cancer patients will enjoy better convenience and accessibility, as well as better treatment results.

(3) Six key elements for establishing a successful oncology business in China

(3) Six key elements for establishing a successful oncology business in China

For biopharmaceutical and biotech companies aiming to establish a successful oncology business in China, the following six key success factors are:

(1) Create a differentiated cutting-edge project portfolio

(1) Create a differentiated cutting-edge project portfolio

Explore differentiation opportunities around patient subgroups, molecular mechanisms of action, and innovative ways to achieve superior clinical benefits.
The wave of innovation beyond traditional small molecules and biological agents has shown great potential in oncology, such as multivalent antibodies, including CAR-T, TCR-T, TIL and other cell therapies, [12] nucleotide-based therapies and Microbial-based therapies (eg oncolytic viruses).
Key measures include systematically evaluating existing investment portfolios and identifying new differentiation opportunities to avoid only following market trends and the strategies of leading companies.
When evaluating these new technology platforms, one should consider the attractiveness of the market, the maturity and innovation of science and technology, and the company's internal capabilities and future ambitions.

(2) Find the right partner and make the most of the combination therapy

(2) Find the right partner and make the most of the combination therapy

Use external partnerships for portfolios other than internal projects to maximize the value of existing core projects and optimize internal resource allocation.
This is also especially true for tumor immunity projects.
In addition to the synergy effect at the project level, the strategic fit of the partners is also an equally important issue, including the unification of development and business capabilities and cultural norms to ensure successful alliance management.

(3) Strengthen local interaction with key opinion leaders (KOL)

(3) Strengthen local interaction with key opinion leaders (KOL)

In this fiercely competitive environment, it is becoming more and more important to have more in-depth contact with Chinese PI.
Participation methods should suit the needs of each KOL.
Typical plans include playing a leadership role or co-leadership role in global clinical trials to increase KOL's global influence, and opportunities to work at an earlier stage of innovation through programs such as translational research such as biomarker research .

(4) Execution, execution and execution-pushing time to the first priority

(4) Execution, execution and execution-pushing time to the first priority

Through optimizing trial design and innovation, accelerating patient recruitment and capacity planning of trial sites, finding opportunities and taking measures that can accelerate development progress without compromising quality.
Although still in its infancy, with the introduction of new technologies, innovative solutions for patient recruitment and trial design have emerged.
For example, due to the lack of a comprehensive database in this increasingly competitive market, recruiting cancer patients is a major challenge faced by many pharmaceutical companies.
Leading local data integrators are using their own databases and proprietary AI algorithms to determine the most suitable patients for recruitment, thereby improving the patient recruitment process.
In China, real-world data can be further used to reduce recruitment costs while ensuring the quality of trials.

(5) Seek all healthy ways to cover China’s 1.
4 billion people

(5) Seek all healthy ways to cover China’s 1.
4 billion people

In addition to the NRDL (National Reimbursement Drug List), commercial health insurance (CHI) and Patient Assistant Program (PAP) should also be explored for a more comprehensive access plan.
No matter which visit plan is adopted, health economics will become more important.
Pharmaceutical companies should also consider developing a comprehensive evidence generation plan and explore early collaborations with PI and data management companies.

(6) Maintain a leading position in the market and lead the construction of an ecosystem

(6) Maintain a leading position in the market and lead the construction of an ecosystem

The tumor treatment market in China is huge, but it is not yet developed.
Pharmaceutical companies have the opportunity to deepen their partnerships with a wider range of Ecosystem 2.
0 stakeholders (such as AI and digital companies and medical data integrators), thereby shaping the tumor ecosystem and leading business model innovation in China.
Many pharmaceutical companies have begun to cooperate with local data companies to carry out tasks ranging from market insight generation, patient recruitment to prospective research and development.
With new fields and opportunities, pharmaceutical companies that are leaders in establishing long-term strategic partnerships with a wider range of stakeholders will be able to better meet China's oncology treatment needs and ensure long-term resilience and success.

to sum up

Summary summary summary

The burden of cancer in China cannot be underestimated.
As the incidence continues to increase, China will continue to face numerous challenges in terms of accessibility and treatment.
Innovation is essential to control this disease, and recent trends indicate that it is expected to help China accelerate the pace of research and development.
China is also focusing on its cancer care ecosystem and infrastructure, and is making encouraging progress in improving patient prognosis and more equitable access to quality medical care and medicines.
For companies developing oncology treatment business in China, the market is still immature, and success depends on the right partnership, local participation and faster time to market.