On August 26, 2022, Hansoh Pharma released its 2022 first half results report. The report shows that in the first half of this year, under the influence of the macro situation and the epidemic, Hansoh Pharma maintained a steady growth in performance, revenue reached RMB 4.434 billion, and revenue from innovative drugs reached RMB 2.321 billion, a year-on-year increase of approximately 84.8% . The proportion of innovative drugs in revenue has increased significantly from 28.5% in the same period in 2021 to 52.3%, a new high.
As of the end of the reporting period, out of the 6 innovative drugs that Hansoh Pharma has launched,5 are Amelox, Hengmu, Hansoh Xinfu, Fulaimei, and Melinda. Innovative drugs have been successfully commercialized. Thanks to the outstanding performance of five innovative drugs, Hansoh Pharma’s innovative transformation has achieved phased success.
In terms of R&D, Hansoh Pharmaceuticals invested in R&D of RMB 739 million in the first half of the year, accounting for about 16.7% of its revenue. The technological layout and speed of advancement are outstanding among leading pharmaceutical companies.
Innovative drugs become the main force of performance growth
Amelo, Hengmu, Haosen Xinfu, Fulaimei, and Melinda, these five innovative drugs have all been included in the National Medical Insurance Catalog, the total sales revenue reached approximately 2.321 billion RMB, accounting for approximately 52.3% of revenue.
Among them, the second-line drug Amelox (Ametinib Mesylate Tablets), which was approved for marketing in 2020, was included in the National Medical Insurance Catalog in that year, and was approved for first-line indications at the end of 2021, driving the Amelo continued to increase its sales volume and became the main force of the company’s performance growth. This year, Amelo’s first-line indications will also participate in the national medical insurance negotiation at the end of the year. If it is successfully included, it is expected to ensure that its sales will continue to increase.
Another blockbuster variety, Hengmu (Tenofovir Amy), was also included in the National Medical Insurance Catalog in 2021 when it was launched. Its market coverage is continuing to expand, and the field of anti-infection is expected to be usher in new growth. Not long ago, on the first anniversary of Hengmu’s launch, Hansoh Pharma interpreted the 96-week data of a large-scale phase III clinical study in detail, which once again confirmed the continuous efficacy and safety of Hengmu, and continued to lay a solid foundation for Hengmu on the academic side.
Haosen Xinfu (flumatinib mesylate tablets), Fulaimei (polyethylene glycol loxenatide injection), Mylingda (morpholinidazole chloride) Innovative drugs such as sodium chloride injection) have maintained good growth.
Meanwhile, Hansoh Pharma will also usher in new innovative drug-driven varieties in the second half of the year. It has introduced the world’s only anti-CD19 monoclonal antibody for the treatment of neuromyelitis optica spectrum disorder (NMOSD). Xinyue (inelizumab injection) was approved in March 2022 and is expected to be launched in the second half of the year. At present, Xinyue has been included in the “Guidelines for the Diagnosis and Treatment of Neuromyelitis Optica Spectrum Diseases in China (2021 Edition)” and has received a Class A recommendation.
In addition, Hansoh Pharma’s the first domestic long-acting EPO drug pemosatide injection is also expected to be approved for marketing within this year. The long-acting preparation has a long half-life, With the advantages of high stability and good patient compliance, it is expected that long-acting preparations will gradually replace short-acting preparations in the future. At present, the proportion of long-acting preparations in the overseas EPO market has exceeded 50%, and the market potential is huge.
In addition, the new indications of a number of innovative drugs are still in progress. With the update of the National Medical Insurance Catalogue, the sales of Hansoh Pharma’s innovative drugs will continue to be released steadily, and the follow-up volume can be expected. .
Heavy scientific research achievements appear in the world
With the commercialization of several innovative drugs, it means that Hansoh Pharma successfully transformed into an innovative pharmaceutical company with innovative drugs to drive performance growth. Behind this is continuous research and development investment. In the first half of the year, Hansoh Pharmaceutical invested about 739 million yuan in research and development, and achieved a number of research progress. Currently, Hansoh Pharma is conducting more than 40 innovative drug clinical trials, involving more than 25 innovative drug projects at different stages, covering 5 major treatments: anti-tumor, central nervous system, anti-infection, metabolism, and autoimmunity field.
In the first half of 2022, there are 3 self-developed clinical projects and 1 BD project. In the first half of this year, Hansoh Pharma has obtained a total of 46 authorized patents in China (including 8 authorized by Hong Kong, Macao and Taiwan), 4 foreign authorized patents, and 7 new products have been approved for marketing, including 1 innovative drug: inelizumab Monoclonal antibody injection (trade name: Xinyue) was approved for the treatment of AQP4 antibody-positive NMOSD adult patients; 4 new marketing applications were submitted, including 1 innovative drug – a class 1 innovative drug pemosatide (formerly Use name: Peihuaxi hippocampal peptide) was newly added for the treatment of anemia in non-dialysis chronic kidney disease patients who did not receive erythropoietin therapy; 6 new applications and clinical approvals were obtained, all related to innovative drugs.
In addition, Hansoh Pharma also actively deploys diversified international frontier new drug technology fields such as siRNA, ADC and fusion protein. In the field of siRNA, Hansoh Pharma has reached strategic cooperation with Silence Therapeutics plc and OliX Pharmaceuticals respectively; in the current most popular ADC track, Hansoh HS-20089 and HS-20093 target B7-H4 and B7-H3 (CD276) respectively. , the above-mentioned varieties are the first varieties of similar drugs to start clinical trials in China, and are expected to seize the first-mover advantage.
In research products, Hansoh Pharma researches and develops independentlyThe PI3Kα inhibitor HS-10352-101, a class 1 innovative drug developed by HS-10352-101, published the research data of the single-agent phase I ramp-up trial at the 113th American Association for Cancer Research (AACR) annual meeting in 2022. Data show that HS-10352 demonstrated favorable safety, tolerability and pharmacokinetics (PK ) characteristics, and observed preliminary anti-tumor activity, and showed better anti-tumor activity in people with PIK3CA mutations, HS-10352 is expected to bring clinical benefits to patients with HR+HER2-PIK3CAm+ advanced breast cancer.
In addition, multiple studies of Hansoh’s number one product, almetinib, are progressing steadily. Multiple clinical studies of almetinib combined with platinum-containing doublet chemotherapy for first-line treatment of NSCLC with sensitive mutations, adjuvant therapy for NSCLC and other indications, will provide more NSCLC patients from early to advanced stage, from perioperative adjuvant therapy, Comprehensive and multi-dimensional drug regimens ranging from second-line and later-line therapy to first-line therapy.
In the first half of this year, the results of the AENEAS study of almetinib were published in the Journal of Clinical Oncology (JCO, IF: 44.544), a well-known international oncology journal; June 2022 , the latest brain metastases subgroup data appeared at the annual meeting of the American Society of Clinical Oncology (ASCO), and the research results have repeatedly amazed the international oncology community. At this year’s International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer (WCLC), almetinib published 21 papers, accounting for 68% of the total, ranking first among all EGFR-TKIs.
Diversified BD models provide continuous power
In addition to continuous investment in research and development, Hansoh Pharma also continues to make efforts in the field of BD. In the first half of this year, Hansoh Pharma not only achieved a number of new authorization and introduction projects, but also continued to steadily advance its innovative drug overseas plan.
In May 2022, Hansoh Pharma and NiKang Therapeutics Inc. entered into a partnership to acquire the exclusive rights to develop and commercialize the HIF2α inhibitor NKT2152 in Greater China, It is expected to be more widely used in the treatment of various tumor types, with a total cooperation value of US$218 million,
Recently, Hansoh Pharma has expanded cooperation with Global Health Drug Research and Development Center (GHDDI), South Korean biomedical research and development company TiumBio, and Beijing Wangshi Smart Technology Co., Ltd. The cooperation includes acquiring the global development, production and commercialization rights of the new anti-COVID-19 drug candidate GDI-4405 series; obtaining the oral non-peptide GnRH receptor antagonist TU2670 in China (including Hong Kong, Macau and Taiwan) ) to develop and commercialize TU2670 for the treatment of endometriosis, uterine fibroids and other potential indications; strategic cooperation in the field of early AI-enabled drug research and development to help improve the efficiency and speed of early research and development of new drugs , reduce costs and increase success rates.
Only the above two introduced products, the total cooperation amount has exceeded 2.5 billion yuan. In fact, driven by a globalized and diversified BD strategy, Hansoh Pharma has reached 16 BD collaborations within three years, becoming one of the most dynamic leading pharmaceutical companies in the BD market. , and achieved excellent results.
In March of this year, Xinyue (Inelizumab Injection), the world’s only anti-CD19 monoclonal antibody for the treatment of neuromyelitis optica spectrum disorder (NMOSD), introduced by Hansoh Pharma was successfully approved in China. This is the first monoclonal antibody drug targeting CD19 in my country, and it is the first blockbuster innovative drug introduced and successfully commercialized by Hansoh Pharma through BD. Another broad-spectrum antifungal drug Ibrexafungerp with a new mechanism of action introduced from Synexis has also been approved for Phase III clinical trials for vulvovaginal candidiasis (VVC) in China, and many of its indications have been approved. in late clinical development.
In terms of going overseas, in June this year, the United Kingdom (MHRA) officially accepted the application for marketing authorization submitted by EQRx, a partner of Hansoh Pharmaceuticals, and the two parties cooperated to develop and commercialize the third-generation EGFR-TKI Ametitinib It is used for the first-line treatment of locally advanced or NSCLC with positive EGFR-sensitizing mutations and for the treatment of locally advanced or metastatic NSCLC that has progressed on previous EGFR-TKI therapy and is positive for T790M mutation. This is the first marketing authorization application for almetinib outside of China.
Hansson Pharmaceuticals’ BD is not limited to pure product introduction, but actively deploys early highly differentiated representative projects, and enriches its business map through equity investment and other forms.
In June 2021, Hansoh Pharma and Cormorant Asset Management co-founded Blossom Biosciences.
In terms of early product cooperation, in October 2021, Hansoh Pharma and Silence Therapeutics plc reached a cooperation to co-develop siRNA drugs based on its unique mRNAi GOLD platform; Subsequently, it entered into a cooperation with OliX Pharmaceuticals to use its GalNAc-asiRNA technology platform to develop drug candidates for liver-related cardiovascular, metabolic and other disease targets.
It can be seen that Hansoh Pharma has adopted a globalization and diversification strategy in BD, and has continuously enriched the choices in disease fields, technology platforms, R&D progress and cooperation models, which is expected to continue to serve the company. Innovative leadership provides a strong drive.
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