Fuhong Henlius successfully concluded the 2021 Service and Trade Fair

Among Chinese pharmaceutical companies, as a representative of a number of innovations that have been harvested after only 11 years of establishment, Henlius is considered young; and the innate international genes and development path make Henlius in Chinese innovative pharmaceutical companies have become an experienced "pilot" on their way to the sea
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2021 Service Trade Fair Fuhong Henlius Booth

On September 2-7, 2021, Henlius will bring a variety of anti-tumor leading results to the China International Trade in Services Fair (hereinafter referred to as the Service Trade Fair), as well as its rich research pipeline and international multi-centers.
The layout of clinical trials and global commercial operation capabilities
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Zhu Jun, Chief Medical Officer and Senior Vice President of Henlius, also conducted a seminar entitled "Chinese Clinical Trials in Global MRCT (International Multi-Center) The report sharing the role of clinical trials", sorted out the evolution of the enlightenment-change-innovation of China's international multi-center clinical trials represented by companies such as Fuhong Henlius
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These innovative achievements and cases are the highlight moments of many years of concentrated deployment of local innovative pharmaceutical companies such as Fuhong Henlius, and they are also the demonstration of China's biological industry's more mature international strength in "talent, technology, product scale" and other aspects
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As China's pharmaceutical policy environment is more and more conducive to the gestation of global original and innovative drugs, Chinese pharmaceutical companies are quickly walking on the road to achieve "global new"
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In such an ecological environment, as the "pioneer of domestically-made biopharmaceuticals going to sea", how will Henlius Group further implement its in China and for Global internationalization strategy in the future?

Zhu Jun, Chief Medical Officer and Senior Vice President of Henlius, pointed out the key factors in the dialogue with Sina Pharmaceuticals
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Before joining Fuhong Henlius in 2021, Zhu Jun has nearly 20 years of industry experience.
He has cooperated with more than 70 local Chinese pharmaceutical companies and biological companies, and led the design and execution of more than 100 clinical trials, covering clinical Ⅰ Until the fourth phase of the trial, he once served as the founder and CEO of Baili Jiasheng China, and the global vice president of IQVIA
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Zhu Jun said that when Chinese innovative pharmaceutical companies go to sea, both legs must be long.
Among them-

The first leg is R&D strength, that is, core products with world-class advantages;

The second leg is clinical transformation and commercial operation capabilities, that is, the ability to control global vision standards and rules, so that more patient groups around the world can effectively enjoy more affordable innovative biopharmaceutical products
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A number of breakthrough "world-class" biological drugs unveiled

A number of breakthrough "world-class" biological drugs unveiled

At this service trade fair, Henlius presented a "star-studded" transcript, three products already on the market and a wealth of pipelines ready to be launched:

The first domestic biosimilar drug Hanlikang® (rituximab);

China's first self-developed Sino-European dual-batch monoclonal antibody drug Hanquyou® (trastuzumab, EU trade name: Zercepac);

The company's first autoimmune disease treatment product Handayuan® (adalimumab);

The company's first innovative biological drug, slulimumab, is expected to become the first domestic "pan-cancer" anti-PD-1 monoclonal antibody for the treatment of highly microsatellite unstable (MSI-H) solid tumors
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It is worth mentioning that these products are world-class heavy varieties, and there is an extremely difficult challenge behind the broad market prospects
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For a long time, biopharmaceuticals have been regarded as the "patents" of world-class pharmaceutical companies due to their numerous and complex preparation processes and extremely high quality system requirements.
It is extremely difficult to reach international first-class standards
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Taking into account the high cost of biologic drugs, especially the extremely low penetration rate of biologic drugs in China, high-quality and affordable biosimilar drugs can not only greatly increase patients’ chances of obtaining “life-saving drugs”, but also The global market brings foreseeable large-scale expenditure savings
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Therefore, from the very beginning of its establishment, Henlius has started from biosimilars and is committed to making domestic biologics with quality comparable to those of the original research

At the same time, due to the international vision of the founding team, Fuhong Henlius started its international strategy of "base on China and go to the world" as soon as it was born
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It is reported that Fuhong Henlius has developed biosimilar drugs in accordance with EU standards from the very beginning.

After "10 years of grinding a sword", Fuhong Henlius finally ushered in three innovative achievements on the market.
Among them, Hanlikon® and Hanquyou® not only have milestones of "groundbreaking", and Handayuan® is also world-class At present, these three products have brought a certain amount of performance to Fuhong Henlius, and under the advantages of Fuhong Henlius' "affordable innovation" concept, the future is expected to continue to increase in volume
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In addition, according to Zhu Jun, the company’s first innovative biological drug, Slulimumab (anti-PD-1 monoclonal antibody), Han Likang® rheumatoid joint indications, and another "biosimilar" large variety of bevacizumab HLX04 Commercialization is also coming soon, which will further bring more abundant cash flow to Fuhong Henlius and help it advance into the "bio-innovative drug" business
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The frontier layout of international innovative drugs both internally and externally

The frontier layout of international innovative drugs both internally and externally

If starting from the biosimilar drug track and benchmarking with the international production quality system, Henlius has taken the lead in taking the lead in a "road with few people walking" and has achieved a certain comparative competitive advantage.
To become a world-class biopharma, it is necessary to accelerate the deployment and transformation of innovative drugs
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How to achieve the world's leading innovative drug layout? In Zhu Jun's view, he needs to work both internally and externally
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1) Internally-independent innovation
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Zhu Jun believes that drug innovation should not only consider breakthroughs in biotechnology, but also the clinical value of drugs, and more consideration should be given to the clinical needs of patients, clinical trial design, and market accessibility
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And the multi-center clinical trials carried out by Fuhong Henlius on a global scale have a lot of patient data outside of China, which has laid a solid foundation for the world's leading innovative drug layout
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Take the fist product of Fuhong Hanli's "innovative drug", Slulimumab (anti-PD-1 monoclonal antibody) as an example
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In the situation where domestic PD-1 competition has become a red sea, slulimumab chooses to differentiate and break through to meet the clinical needs of patients that are not covered

It is reported that slulimumab "pan-cancer" treatment of highly microsatellite unstable (MSI-H) solid tumors has been submitted for domestic market registration and is expected to be approved in the first half of 2022, becoming the first domestic treatment Anti-PD-1 monoclonal antibody for MSI-H solid tumors
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Microsatellite instability (MSI) is common in a variety of tumors, including colorectal cancer, endometrial cancer, gastric cancer, hepatocellular carcinoma, melanoma, etc.

In addition, according to Zhu Jun, compared with other local PD-1 product developers, another advantage of slulimumab is the fully launched "Combo+Global" (combination therapy + internationalization) strategy.
With slulimumab as the core, in combination with other drugs, a number of clinical trials have been launched worldwide to explore the treatment of multiple high-incidence large tumors such as lung cancer, hepatocellular carcinoma, gastric cancer, esophageal cancer, and head and neck cancer
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Among them, the layout of the first-line treatment for multiple indications of lung cancer is an important killer of slulizumab, and slulizumab is expected to become the first approved PD-1 product for small cell lung cancer

At the same time, the research and development of products such as Fuhong Hanli's double antibody innovation has also ushered in new progress, including HLX301 (bispecific antibody containing TIGIT target) and HLX35 (bispecific antibody containing 4-1BB target) The preliminary preclinical in vitro and in vivo studies and cell line development have been completed, and further preclinical evaluations are underway.
It is expected that relevant clinical trial applications will be submitted soon
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2) External——license in
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While the results of independent research and development pipelines are beginning to show, Fuhong Henlius is also actively seeking external sources to make up for and strengthen its own innovation pipelines and capabilities
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It is reported that this year, Henlius has reached two major license in cooperation

→In May 2021, Henlius and Runxin Biotechnology entered into a license agreement for the small molecule inhibitor RX208 (HLX208) that targets the V600E mutation of human BRAF protein
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This cooperation has accelerated the diversified innovation of Henlius and enhanced the company's product targets and variety

→In January 2021, Henlius and Chiome reached a cooperation on TROP-2 (trophoblast cell surface antigen 2) monoclonal antibody.
TROP-2 is used in triple-negative breast cancer, non-small cell lung cancer, urothelial Over-expression is present in all types of solid tumors, which are expected to become therapeutic targets with broad-spectrum anti-tumor effects, and have development potential in antibody-conjugated drugs (ADC), bispecific antibodies, and combination therapies
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In addition, according to Zhu Jun, Henlius will also focus on innovative potential targets, dual-target antibody platforms, ADC products, radioimmunotherapy, etc.
in the future
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Synchronize the global navigation path of first-class enterprises

Synchronize the global navigation path of first-class enterprises

In order to become a world-class innovative pharmaceutical company, in addition to the world's leading product layout, clinical translation capabilities and commercial operation strength are also indispensable parts
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Zhu Jun called the team he led "GPD": Global Product Development, the global product development department, including clinical operations, medicine, data, clinical compliance and quality assurance, pharmacovigilance, and drug administration affairs.
Pharmaceutical administration registration system
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In his view, with the joining of more and more talents with international background and local practical experience, and under the talent training and incentive policies of Fuhong Henlius, the current team of Fuhong Henlius from R&D, to BD, When it comes to management, it is already a stable and globally integrated team
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Such an international team not only allows Henlius to have the most cutting-edge vision in the world, but also has the ability to control international standards and regulations.
This allows Henlius to realize the "global new" development path, not only Timely and effective communication with FDA and other foreign regulatory agencies can also effectively integrate technological innovation and standardization construction, and accelerate the promotion of various technological innovation achievements against international standards
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In addition, in terms of clinical transformation, with the joining and advancement of Zhu Jun, the current clinical transformation team of Fuhong Henlius has been accelerated, and independent research and development has been further realized
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In terms of production, Henlius’ existing and under-construction biomedicine commercialization base has a total production capacity of 80,000 liters, of which the Xuhui base has an existing production capacity of 20,000 liters.
It is already the first domestic company to obtain EU GMP certification for the production of self-developed antibody biopharmaceuticals.
The GMP factory is currently expanding its production capacity and plans to add a pre-filled needle production line this year; in addition, its Songjiang base (1) has completed all 12 2,000-liter bioreactors in the original liquid line, a total of 24,000 liters of production capacity and the confirmation of the commissioning of the preparation freeze-drying line As well as multiple batches of process verification and production, Songjiang Base (2) is also under accelerated construction.
The project has a designed capacity of 36,000 liters to meet the commercialization needs of more products after they are launched
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In terms of commercialization, in addition to the strong support of Fosun Pharma, the commercialization team that Fuhong Henlius is building, and the exploration of more international cooperation and laying channels, in order to reach more patients in need around the world faster in the future
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"The only way to get rid of internal volume is external volume" is currently the hottest topic in the industry
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In the context of increasingly fierce domestic competition, Henlius's overseas route may reflect the choice of a deeper reform route for China's innovative pharmaceutical companies
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Although there is still a certain gap with the world-class pharmaceutical companies, the more mature international strength that Fuhong Henlius has tempered in more than 10 years has gradually revealed its edge and courage
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In the dialogue, Zhu Jun also lamented many times that at present, many aspects of China have reached the world's leading level.
This is an era of fierce competition, but it is also the best era
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Biomedicine is regarded as the most promising field for Chinese medicine to overtake and become a field comparable to world-class pharmaceutical companies.
In the future, as the "pioneer of domestically-made biopharmaceuticals", how will Fuhong Henlius compete in the international arena? , Sina Pharmaceuticals will continue to pay attention
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