The performance of innovative drugs is bright, self -developed+BD high -speed driver, Hansen Pharmaceutical creates innovative samples

On August 26, 2022, Hansen Pharmaceutical released the performance report in the first half of 2022. The report shows that under the influence of macro situations and epidemic in the first half of this year, Hansen Pharmaceutical maintained a steady performance growth, revenue reached RMB 4.434 billion, and innovative drug revenue was 2.321 billion yuan, an increase of about 84.8%year -on -year. Innovative drugs have increased significantly from 28.5%in the same period of 2021 to 52.3%, a new high.

As of the end of the reporting period, of the six innovative drugs that Hanson Pharmaceutical had been listed, 5 innovative drugs including Amle, Hengmu, Haosen Xinfu, Fu Laimei, and Minda have successfully commercialized. Thanks to the excellent performance of 5 innovative drugs, Hanson Pharmaceutical Innovation Transformation has achieved phased success.

In terms of R & D, Hansen Pharmaceutical's research and development investment in the first half of the year was RMB 739 million, accounting for about 16.7%of the income, maintaining a continuous growth trend, and its cutting -edge scientific and technological layout and advancement speed performed well in head pharmaceutical companies.

The main force of innovative medicines for performance growth

The five innovative drugs, Amele, Hengmu, Housen, Fumei, and Minda, were included in the national medical insurance directory. The total sales revenue reached about 2.321 billion yuan, accounting for about 52.3%of the income.

Among them, the second -line medication of Amele (oxal sulfonic acid), which was approved in 2020, was included in the national medical insurance catalog in that year. The first -line indications were approved at the end of 2021, which led Amele to continue to sell in sales and became the company to become a company. The main force of performance growth. This year, Amele's front -line indications will also participate in the national medical insurance negotiations at the end of the year.

Another heavy -duty variety Hengmu (Emidoovovir) was also included in the national medical insurance directory when it was listed in 2021. Its market coverage is continuously expanding, and the field of anti -infection is expected to usher in new growth. Not long ago, on the first anniversary of Heng Mu's listing, Hansen Pharmaceutical interpreted the 96 -week data of the large -scale phase III clinical research in detail, once again confirmed the continuous efficacy and security of Heng Mu, and continued to consolidate the foundation on the academic end.

Hamson Xinfu (methadonial fluumidininib), Fu Laimei (polyethylene glycol Losnaptide injection), Magoline (sodium namarzole sodium chloride injection) and other innovative drugs are maintained Good growth.

At the same time, Hansen Pharmaceutical will also usher in a new innovative drug -driven variety in the second half of the year. The world's only anti -CD19 Mupage Anti -Anti -Anti -Anti -Anti -Anti -Anti -Anti -Anti -Anti -Anti -Anti -Anti -Anti -Anti -Anti -Anti -Note injection in the world ’s only treated optic neuropitis spectrum (NMOSD) is introduced at 2022 It is approved in March and is expected to be listed in the second half of the year. At present, Xinyue has been included in the "Guidelines for the Diagnosis and Treatment of Conditional Cypical Cypical Cypical Diseases (2021)" and obtained Class A recommendation.

In addition, Hansen Pharmaceutical's first domestically produced long -term EPO drug Peimosa peptide injection is also expected to be approved to be listed during the year. Long -term preparations have the advantages of long -period, high stability, and good patient compliance. It is expected that the future long -acting preparation will be expected to be in the future. Gradually replace short -acting preparations. At present, the proportion of long -acting agents in the overseas EPO market has exceeded 50%, and the market potential is huge.

In addition, the new indications of a variety of innovative drugs are still being promoted. With the update of the national medical insurance directory, the sales of Hanson Pharmaceutical Innovation drugs will still be released steadily, and the subsequent volume can be expected.

The results of heavy scientific research appear on international

With multiple innovative drugs entering commercialization, it means that Hansen Pharmaceutical's smooth transformation is a innovative pharmaceutical company that drives the growth of innovative drugs. Behind this is the continuous investment in R & D. In the first half of the year, Hansen Pharmaceutical R & D investment was about 739 million yuan, and a number of research progress has been achieved. At present, Hansen Pharmaceutical has more than 40 clinical trials of innovative drugs, involving more than 25 innovative drug projects at different stages, covering five therapeutic fields of anti -tumor, central nervous system, anti -infection, metabolism, and autoimmune.

In the first half of 2022, there were 3 self -developed projects and 1 BD project. In the first half of this year, Hansen Pharmaceutical obtained a total of 46 authorized patents in China (including 8 authorized Hong Kong, Macao and Taiwan), 4 foreign authorized patents, and 7 new products were approved to be listed, including 1 innovative medicine: Inaily Zhuzhu A monoclonal injection (commodity name: Xinyue) was approved by the treatment of AQP4 antibody -positive NMOSD adult patients; 4 newly submitted listing applications, including 1 innovative medicine -1 Category 1 Innovation Pharmaceutical Peng Mosha (Zeng Zeng Name: Cultivate West Hema Peptide) newly added anemia for non -dialysis patients who have not accepted the treatment of red blood cells. The new declaration and obtaining 6 clinical approvals are all innovative drugs.

In addition, Hansen Pharmaceutical also actively deployed diversified international frontier new drug technology fields such as SiRNA, ADC and fusion protein. In the field of SIRNA, Hansen Pharmaceuticals reached strategic cooperation with Silence therapeuticsPlc and Olix Pharmaceuticals; in the most popular ADC tracks at the moment, HS-20089 and HS-20093 are targeted at B7-H4 and B7-H3 (CD276). The above varieties are the first clinical varieties in China to launch clinical varieties, which are expected to seize the advantages of first -mover.

In terms of research products, HS-10352-101 independently developed by Hansen Pharmaceutical Pi3Kα inhibitor HS-10352-101 announced at the annual meeting of the 113rd American Cancer Research Association (AACR) annual meeting Essence Data show that HR+HER2-advanced breast cancer subjects who have no standard treatment plan or cannot be obtained or inability to get tolerance are displayed in HS-10352. ) Features, and observed preliminary anti-tumor activity, and showing better anti-tumor activity in carrying PIK3CA mutations, HS-10352 is expected to bring clinical benefits to HR+HEK3CAM+late breast cancer patients. In addition, many studies of Asleinib products in Hansen Pharmaceutical's number one product are also steadily promoting. Amerininib combined with many clinical studies such as sensitive mutations NSCLC and auxiliary therapy NSCLC and other indications for the first -line therapy of platinum -containing bilateral chemotherapy, which will provide more NSCLC patients with early to late period, from perimenia, second -line and post -surgery period, second -line and post -after -line and post -sub -post -surgery period, second -line and post -after -line Comprehensive multi -dimensional medication solutions such as line treatment to front -line treatment.

In the first half of this year, the results of Ameitinib Aeneas' studies were published in the International Oncology Journal "Journal of Clinical Oncology, IF: 44.544); in June 2022, the latest brain metastased Asian group data appeared in the United States clinical in the United States. The Annual Meeting of the Cancer Society (ASCO), the research results have repeatedly stunned the international oncology. At this year's International Cancer Research Association (IASLC) World Lung Cancer Conference (WCLC), 21 Amerinib published results, accounting for 68%of the total number, ranking first among all EGFR-TKIs.

Diversity BD mode provides continuous motivation

In addition to continuous investment in research and development, Hansen Pharmaceutical continues to work in the BD field. In the first half of this year, Hansen Pharmaceuticals not only reached multiple new authorized introduction projects, but also continued to advance steadily.

In May 2022, Hansen Pharmaceutical reached a cooperation with Nikang Therapeutics Inc. to obtain the exclusive rights of the development and commercialization of HIF2α inhibitors NKT2152 in Greater China. It is expected to be widely used in the treatment of various types of tumor, with a total cooperation of 2.18 One hundred million U.S. dollars,

Just recently, Hansen Pharmaceuticals expanded cooperation with Global Health Drug Research and development Center (GHDDI), Korean biomedical research and development company Tiumbio, and Beijing Wangshi Smart Technology Co., Ltd. The content of the cooperation includes the global development, production and commercialization rights of the new crown virus candidate for the new crown virus candidate for the new drug GDI-4405 series; the exclusive license agreement of oral non-peptide GNRH receptor antagonist TU2670 in China (including Hong Kong, Macau and Taiwan), development And commercialized TU2670 for the treatment of endometriosis, uterine fibroids, and other potential indications; strategic cooperation in the early research and development field of AI empowerment drugs to help new drugs and increase the speed of efficiency, reduce costs, and increase success rates Essence

Only the above two introduced products, the total cooperation amount has exceeded 2.5 billion yuan. In fact, driven by the global and diversified BD strategy, Hansen Pharmaceutical has reached 16 BD cooperation within three years, becoming one of the most dynamic head pharmaceutical companies in the BD market, and achieved excellent results.

In March of this year, the world's only anti -CD19 Mupido Xinyue (Inalyzumab injection) was successfully approved in China in China. CD19's monoclonal anti -anti -anti -drug is the first heavy innovative drug introduced by Hansen Pharmaceutical through BD and successfully commercialized. Another broad -spectrum antifungal drug IbrexaFungerp, which introduced a new function mechanism from Synexis, has also been allowed to carry out phase III clinical trials for vulva and vulvaotids (VVC) in China. Its multiple indications have been in the later clinical development stage.

In terms of going to sea, in June this year, the British (MHRA) officially accepted the listing license application submitted by the Hansen Pharmaceutical partner EQRX. Late or NSCLC and used to treat previously advanced or transformed NSCLC for the treatment of EGFR-TKI and T790M mutant positive. This is the first application for listing permit outside China.

Hansen Pharmaceutical is not limited to the introduction of simple products on BD, but actively deployed the early high -differential representative project, and enriched business landscapes through equity investment.

In June 2021, the Blossom Biosciences of Hanson Pharmaceutical and Cormorant Asset Management.

In the early product cooperation, in October 2021, Hansen Pharmaceutical reached a cooperation with Silence TherapeuticsPlc to develop SIRNA drugs based on its unique MRNAI GOLD platform; and then reached a cooperation with Olix Pharmaceuticals to use its Galnac-Asirna technology platform for the liver.Related cardiovascular, metabolism and other disease target development candidate drugs.It can be seen that Hansen Pharmaceutical has adopted a global and diversified strategy on BD. The choice of choices in the field of disease, technical platforms, R & D progress and cooperation models is continuously enriched, and it is expected to provide strong driving for the company's continuous innovation.

#Hansen Pharmaceutical ## Ameitinib#

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