PD-1 goes out of the trough, Junshi creatures are building tumor drug matrix

On the evening of August 30, Junshi Biological (688180.SH/1877.HK) disclosed the 2022 mid -term performance report. In the first half of the year, the company achieved a total revenue of about 946 million yuan. Among them, the core product PD-1 Tripley's sales revenue was about 298 million yuan, an increase of about 195.93%from the previous half of 2021.

The domestic epidemic is repeated, but the performance of Tripley Mipide in the first two quarters of this year is still steadily rising, and sales have improved quarter -on -quarter. This is a very difficult progress in Chinese biomedical companies under the epidemic.

The interim report of the Junshi creature seems to be bland, but it actually contains a lot of key information about the reverse wind turning. Whether it is the adjustment of domestic performance after the company's commercial team, the internationalization of "going to the sea", or the layout of the key tumor R & D pipelines issued by A shares, it is quite interesting.

Everyone is optimistic about the sense of mind, but in the adversity, it can have toughness and self -adjustment ability, and seek the long -term layout and investment in the future. This is the company's self -confidence in the future development of future development.

PD-1 income actually increases significantly

Junshi's PD-1 Tripley Mipide has released some positive signals in domestic sales.

In the first half of this year, Junshi has completed the adjustment of the commercial team and supplemented the core market personnel. As of June, the company's commercial team has exceeded 1,100.

From the perspective of configuration, Li Cong, as a co -CEO of the company, is fully responsible for commercialization. Each functional team personnel set up under the commercialization department have rich experience in drug promotion and commercialization in the field of tumor fields. The sales directors of various regions in China have the tenure experience of multinational pharmaceutical companies. They have more than ten years of experience in anti -tumor innovation drug promotion experience. Anti -waiting, all of them are widely used for extensive anti -tumor drugs.

The reorganization of the Junshi commercial team has attracted much attention from the outside world. It can be seen that the new sales team brought a significant improvement to the commercialization of Tripley monoclonal resistance.

In terms of quarterly, the Junshi biological revenue in the first quarter was approximately 630 million yuan, of which PD-1 revenue was 110 million yuan, an increase of 211.69%month-on-month; in the second quarter, Shanghai, Jilin and other local sales promotion activities and logistics were greatly affected , But PD-1 still maintains further growth, achieving sales revenue of 188 million yuan, an increase of 70.91%month-on-month. Moreover, sales in June have been significantly increased than in April and May, showing that the domestic sales of Junshi PD-1 have gradually recovered and entered a positive cycle.

After holding the influence of the epidemic, the biggest opportunity for Tripley monoclonal resistance to gradually entered the harvest period.

PD-1 is a recognized wide-spectrum anti-tumor product. In terms of the expansion of the adaptive expansion of the product, the product adopted "small indications+large indications", "cut in from the end line, quickly advance to the front line and perioperative surgery period "Treatment" strategy.

In May of this year, Tripley Metrics combined with paclitaxel and cisplatin for non -removal of new indications for first -line treatment of patients with advanced/recurrence or remote metastatic esophageal squamous carcinoma. This is the fifth indicator of Tripley Mipide's approval in China after melanoma, nasopharyngeal cancer, and urinary tract. It is also the first major indicator.

At the same time, the adaptability of Tripley monoclonal first -line treatment of non -small cell lung cancer is also in the review stage. In addition, multiple adaptive diseases are in the clinical phase of the III stage, including lung cancer, liver cancer, breast cancer, etc. with higher incidence, etc. Essence

From 2022 to 2023, Junshi Bio is expected to usher in the harvest period of Tripley monoclonal anti -resistance. In addition, Tripley Mippy also has a forward -looking layout of non -small cell lung cancer, liver cancer, gastric cancer, and esophageal cancer.

At the same time, Junshi creatures also have a strong backing of production capacity. In May of this year, Junshi Shanghai Lingang production base was approved, and Tripley Metropolis increased 30,000 commercial production capacity. This enables Junshi to impact the market with a more competitive cost advantage, and also make full production capacity reserves for other research products on the pipeline.

Data source: Junshi Biological 2022 Interim Report Performance

The commercialization team has gradually stabilized, the domestic epidemic situation is relieved, and the major adaptability of Tripley monoclonal anti -resistance has entered the stage of approval, especially the esophageal squamous carcinoma, lung cancer, etc. These are all conducive to the Tripley monetta in China. Sales have been further improved.

In terms of products, in March 2022, Junshi added a heavy commercial product: "Medicine King" Adamab's anti -anti -anti -anti -anti -anticipation of rheumatoid arthritis, ankylosing spondylitis and psoriasis Get NMPA approval. In August, Ada Mipida's supplementary applications for the treatment of 5 indications such as Crohn's disease, uveitis, and multi -joint young special arthritis were also received.

In addition, there are multiple varieties on the Junshi pipeline near commercialization, such as PARP inhibitors, Anggorese monetab, Bevarzab, and VV116 are in the phase III clinical trial stage. These products are expected to bring new income growth points to Junshi.

"Go to the sea" still has the chance of incremental increase

Junshi is one of the earliest innovative pharmaceutical companies in China to launch an international strategy. Overseas commercialization is also expected to bring continuous market growth.

Tripley monoclonal anti-anti-resistance is China's first domestic PD-1 application to the FDA. At present, Tripley Mipide combined with the first -line therapy and single drug for the first -line treatment of advanced recurrence or metastatic nasopharyngeal cancer for recurrence or metastatic nasopharyngeal cancer. Biological Products License Application) is under FDA review. According to the FDA regulations, the final review date of the above indications is December 23, 2022. At that time, if Tripley Mutterum can be approved to be listed in the United States, Junshi will organize the US market to promote the US market in the first quarter of 2023. At that time, Tripley Midumi will become the first in the United States The only tumor immunotherapy for nasopharyngeal cancer treatment.

Data source: Junshi Biological 2022 Interim Report Performance

It is worth mentioning that in April of this year, Tripley's anti -counterfeit was used for the treatment of small cell lung cancer to obtain FDA issued orphans. In July, Tripley Mipide was used to treat nasopharyngeal cancer and obtained the qualifications of orphan drugs awarded by the European Commission.

By the first half of this year, Tripley Meticulous has obtained a total of 6 orphan drug qualifications, 2 breakthrough therapy identification, and 1 fast channel identification by the European Union and the United States drug regulatory agency. This will further accelerate the PD -1 "going to sea" process.

As early as PD-1, Jun Shi actually had successful experience in overseas commercialization, and received the fruits of "going to the sea" in China's innovative medicine. The new crown and antibody Etzwe monocidal (JS016) and the Eli Barnifer monoclonal antibody therapy for the development of the new crown and antibody Etzwe (JS016) and Eli Lili have been developed. All milestones agreed in the Lilly License Agreement were also reached.

In 2021, Junshi received a technical license and franchise use fee of RMB 2.366 billion.

Jun Shi chose COHERUS, as a commercial partner of the PD-1 North American market, has received $ 150 million in down payment, and the cumulative milestone model does not exceed 380 million US dollars. It is expected that after Tripley's resisted FDA approved listing, Junshi can get a 20%division of net sales, and the incremental space is huge.

The tumor drug matrix is ​​worth looking forward to

From the perspective of the world, the number of tumor patients is huge and the incidence is on the rise. At present, there are still huge and uncomfortable clinical needs.

As the popular disease field of "arms must fight", the competition in the domestic tumor market will be a long -term and comprehensive contest, rather than a short -term combination of short soldiers in a year and two years. Autonomous research and development capabilities are the foundation of standing. Enterprises need to have the ability to continuously iterate new products and new technologies and differentiated R & D pipelines. Above this, it is also necessary to actively explore the use of drugs to achieve efficient synergy between products to cope with fierce market competition.

There are more than 50 candidate drugs in the R & D pipeline, about 80%of them are anti -tumor products. In the first half of this year, Junshi Bio announced the directional issuance plan, which plans to raise nearly 4 billion yuan, mainly investing in the research and development project of anti -tumor innovation drugs, including multiple target tumor drugs in early research. The beneficiary and treatment effect of therapy.

Among them, Junshi plans to invest 860 million yuan for subsequent domestic and overseas R & D for Tripley monoclonal anti -resistance, including adenocarcinoma in the gastric or gastric duct adenocarcinoma, advanced hepatobiliary tube cancer and other indications. In addition, it invested 865 million yuan for anti -BTLA monoclonal tifmalimab, invested 505 million yuan for domestic and overseas research and development of Tigit monoclonal anti -anti -JS006, as well as the joint projects of Tripley Midami and other new drugs.

Junshi creatures not only make a good layout in the width of the pipeline, but also make full consideration in thickness. PD-1 is the cornerstone drug of tumor immunotherapy. Junshi's anti-tumor R & D pipeline focuses on synergistic complementarity to solve the existing primary drug resistance and obtaining drug resistance of tumor immune.

Junshi creatures are actively exploring the use of "IO+IO" between immune checkpoints inhibitors, as well as the combination of IO drugs and various technical types, including small molecules and ADC drugs, in order to combat tumors in multiple dimensions.

For example, in order to solve the problem of drug resistance after PD-1 treatment, Junshi actively explored a combined treatment strategy based on the characteristics of the patient's immune micro-environment. Pully Mipida combined treatment plan.

Data source: Junshi Biological 2022 Interim Report Performance

For another example, in order to solve the problem of cold tumors in tumor immunotherapy, Junshi has developed a number of projects such as anti -CD93 monoclonal and anti -CD39 monoclonal anti -anti -CD39 monoclonal anti -anti -CD39 monoclonal antibodies targeted at the normalization of immune microcirculation microvascular blood vessels.

In order to solve the lack of or only little tumor-specific T cells that are lacking or only, they cannot respond to immunotherapy, and the long-term IL-21 and other products have been deployed in the pipeline. Lijibu has a good synergy effect.

In the anti-tumor drug research and development matrix of the Junshi layout, there are no lack of potential first-in-class or Best-in-Class.

TIFCEMALIMAB is the first First-in-Class product of Junshi. The internal number is JS004. Junshi organizes the IB/II test in China and the United States. At present, there is no target anti-tumor product in the world to enter clinical trials.At the beginning of June this year, TIFCEMALIMAB announced the first time in the American Clinical Oncology Society that lymphoma and physical tumor treatment data were announced. The safety was good and the effect was initial.Some small molecules of anti -tumor drugs in the Junshi Rampage project, such as JS110, JS111, JS112, etc. are all potential varieties.

Exploring the innovative drug combination, the multi -dimensional anti -tumor drug matrix, solve the patient's core competitiveness in the field of tumor immune in the field of tumor immunity while not meeting more clinical needs.This is the basic market for Junshi to continue to create surprises for investors in the future.

Writing | Jian Zhijun

Edit ｜ Jiang Yun Jia Ting

Operation | Valley

Illustration | Visual China

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