Great strides into the harvest season!

On August 25, CStone Pharmaceuticals, a Hong Kong-based innovative pharmaceutical company, released its 2022 semi-annual report.

At the same time, CStone also announced the change of management.

According to the financial report, despite being affected by uncertain factors such as the epidemic in the first half of the year, the sales of 3 drugs under CStone Pharmaceuticals, including Taijihua®, Pujihua® and the newly launched Tuoshuvo®, still reached RMB 161.

Change of company management

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Revenue paths are increasingly diversified

Commercialization accelerates market penetration

A number of financial report data show that with the efficient transformation of R&D results and the release of comprehensive commercialization capabilities, CStone's self-hematopoietic ability has been further enhanced and has entered the commercial harvest period

It is worth noting that the 4 products of CStone are the first of its kind/best-in-class/first-tier potential, and have no competitors in the market

It is potentially the best in its class and is currently the only PD-(L)1 antibody drug in the world that covers both stage III and IV small cell lung cancer (NSCLC) populations

In addition, CStone further penetrated in the dimension of market expansion

According to the financial report, CStone will use digital platforms, cooperate with next-generation sequencing companies and the National Center for Pathology Quality Control, promote hospital and DTP listing, optimize pricing strategies, and optimize innovative payment plans.

Comprehensive acceleration of multi-stage clinical development

Strong R&D pipeline with sufficient reserves

Thanks to its strong clinical R&D capabilities and R&D investment, CStone has expanded into more diverse product areas, and a number of marketed products have made breakthroughs in the expansion of indications, promoting the development of Pipeline 2.

In the first half of the year, CStone received 4 NDA approvals for 3 products, including Zejimet® approved in mainland China for the treatment of stage III non-NSCLC, becoming the only anti-PD-2 drug in the world approved for both stage III and IV NSCLC patients.

At the same time, CStone also submitted 2 NDA applications, including the NDA application of Pujihua® for the treatment of RET fusion-positive NSCLC and TC, and RET-mutant MTC in Taiwan, and the submission of Pujihua® in Hong Kong, China for the treatment of RET NDA filing for fusion-positive NSCLC

In terms of early pipeline, the potential global best-in-class drug CS5001 (ROR1 ADC) has been approved for clinical use in the United States, Australia and mainland China, and an international multi-center first-in-human trial has been initiated in the United States.

In addition, in the first half of the year, the company presented 7 related data at global academic conferences or published 7 related data in top medical journals, including being invited to present 4 reports at the 2022 ASCO Annual Meeting and the 2022 World Lung Cancer Congress to present relevant data, and in the "New England" The relevant data were published three times in the Medical Journal and The Lancet·Oncology
.

According to the company's plan, CStone Pharmaceuticals plans to have 3 NDAs approved, 6 NDA applications submitted, and 4 global research data released in the next year, with sufficient reserves of subsequent diversified pipelines to provide continuous growth momentum for future development
.

Both internal and external training, external strategic cooperation is getting better

Internal cost reduction and efficiency increase to improve profitability

CStone's semi-annual report also pointed out that CStone continued to develop and deepen its relationships with major strategic partners around the world, and to expand the commercialization of both marketed and late-stage drugs
.

In the Chinese market, the cooperation between CStone and Ruihui has made significant progress
.
In May 2022, the second indication of Zejimei was approved for the improvement of consolidation therapy in patients with stage III NSCLC with progression-free survival after concurrent or sequential platinum-based chemoradiotherapy; lorlatinib in the treatment of ROS1-positive advanced NSCLC The joint development program will achieve the first patient enrollment in the pivotal study in May 2022
.
Since last year, CStone and Hengrui have established a strategic partnership to accelerate the development and commercialization of anti-CTLA-4 monoclonal antibody (CS1002) by leveraging their respective R&D and commercial expertise to fully unlock its commercial value
.

In the international market, CStone has cooperated with EQRx to conduct regulatory applications for the registration of Zejimei NSCLC and ENKTL indications in many countries and regions around the world, including the United States, the United Kingdom and the European Union, to explore the feasibility of further expanding the indications of the drug in the global market.
(including gastric and esophageal cancer), a global Phase III study of nofazinlimab in the treatment of HCC in the US and major EU markets
.

Internally, independent research at the company's new global R&D center and collaboration with business partners will strengthen the model for acquiring innovations, consolidate the company's advantages in immuno-oncology therapy and precision therapy, and enhance the ability to submit 1 to 2 INDs per year ability to achieve long-term goals
.
At the same time, the company is currently undergoing technology transfer for a number of products.
In July 2022, it will complete the submission of the technology transfer application for Pujihua® to the Center for Drug Evaluation (CDE) of the State Food and Drug Administration.
In the future, it will reduce the cost of the product and improve the long-term profitability
.

At the same time, CStone's global industrialization base has started trial operation and is preparing for commercial-scale production
.
The production site has the capacity to produce 26,000 liters of biologics and 1 billion small molecule tablets, either for clinical trials or for commercial sale
.
With the decline in production costs, the commercial value of more products has been released, and the long-term profitability of products has been improved, and CStone has made great strides into the harvest period
.