The first in the world! Huadong Pharmaceutical's new FRα target ADC was approved by the FDA

On November 15, Huadong Medicine (000963. SZ) announced that its US partner ImmunoGen, Inc. announced that its world's first (first-in-class) ADC drug ELAHERE™ (mirvetuximab soravtansine-gynx, research and development code: IMGN853, HDM2002) for the treatment of platinum-resistant ovarian cancer has been approved by the US Food and Drug Administration (FDA) for accelerated marketing.

ELAHERE™ thus became the first FDA-approved ADC drug for platinum-resistant ovarian cancer for adult patients with platinum-resistant ovarian epithelial carcinoma, fallopian tube carcinoma or primary peritoneal cancer who received a 1- to 3-line systemic regimen with positive folate receptor α (FRα).

The world's first FRα-targeted ADC drug

The BLA application will be submitted in the second half of 2023

Huadong Medicine said that ELAHERE™ is the world's first FRα-target ADC drug and is a key product under development in the company's tumor innovative drug pipeline. ELAHERE's™ accelerated listing approval in the United States has had a positive impact on its approval in China. The company will continue to fully carry out the clinical development and registration of this product in China, and promote its early benefit to Chinese ovarian cancer patients.

Huadong Pharmaceutical has the exclusive clinical development and commercialization rights of ELAHERE™ in Greater China (including Chinese mainland, Hong Kong, Macau and Taiwan), and the company plans to submit a BLA application to NMPA in the second half of 2023.

Ovarian cancer is known as the "king of women's cancer", with the third annual incidence rate of female reproductive system tumors and the first mortality rate among gynecological malignant tumors. Globally, about 250,000 women are diagnosed with ovarian cancer each year, and 140,000 people die, and about 70% of ovarian cancers are diagnosed at an advanced stage, with a 5-year survival rate of only 30%. According to the National Cancer Center: National Cancer Report 2022, the number of ovarian cancer cases in 2020 was 55,000, and the number of cases is slowly increasing every year. This makes ovarian cancer the gynaecological malignancy with the highest mortality rate and the lowest survival rate.

Platinum-resistant ovarian cancer is a refractory disease, short survival, there is a serious unmet clinical need, since 2014 the US FDA has not approved new therapies for this indication, this ELAHERE™ accelerated approval is a huge breakthrough in the field of ovarian cancer treatment.

ELAHERE™ is approved based on objective response rate (ORR) and duration of response (DOR) data from the pivotal SORAYA trial, based on the FDA's accelerated approval pathway.

The SORAYA trial is a single-arm study of 106 patients with platinum-resistant ovarian cancer who are high FRα expression, have previously received 1-3 line regimens, and have received at least first-line Avastin-containing® therapy. The primary endpoint of the study was investigator-assessed ORR, with the key secondary endpoint being DOR. The investigators assessed an ORR of 31.7% (95% confidence interval [CI]: 22.9, 41.6), including 5 complete responses (CR). The median DOR assessed by the investigators was 6.9 months (95% CI: 5.6, 9.7).

ImmunoGen is conducting another international multicenter, randomized, controlled phase III study (MIRASOL study). The MIRASOL study, a confirmatory pivotal clinical trial designed to convert accelerated approval of ELAHERE™ to full approval, has now completed full subject enrollment, and ImmunoGen expects to have top-line data available in early 2023. In July 2022, its phase I clinical trial PK pharmacokinetic study in China completed the enrollment of all subjects. In August 2022, its first patient enrollment in the phase III single-arm clinical trial in China was completed, and it is expected that all subjects will be enrolled by the end of 2022.

Differentiated depth layout

10 ADC new drugs will be completed in 3 years

In recent years, Huadong Pharmaceutical has continued to increase its differentiated and in-depth layout in the field of ADC, and has successively invested in the antibody R&D and production company Quanxin Biotechnology, ADC linker and conjugation technology company Norin Biotechnology, incubated Hunda Biologics, which has the full product line of ADC drug toxin raw materials, and controlled the multi-antibody platform R&D company Doier Biotechnology.

In September 2022, Huadong Pharmaceutical successfully completed its equity investment in Heidelberg Pharma, a German listed company, becoming its second largest shareholder, forming a unique ADC global R&D ecosystem for Huadong Pharma. At present, Huadong Medicine has established an independent ADC R&D center, and plans to develop no less than 10 ADC innovative products within three years and actively promote registered clinical research.

In the field of oncology, Huadong Pharmaceutical's product under development is a class 1 innovative drug Maihuatinib tablets, which is used for the treatment of advanced non-small cell lung cancer, and has completed the overall enrollment of phase III clinical subjects, and is expected to carry out marketing application after the completion of phase III clinical trials in the second quarter of 2023. Icariin softgels, a national class 1 innovative drug for small molecule immunomodulation, has been officially commercialized and marketed in May 2022.

Huadong Medicine liraglutide injection is the earliest domestic drug to submit a marketing application for diabetes indications, and its marketing application was accepted by the State Food and Drug Administration in September 2021. In July this year, the marketing authorization application for the weight loss indication of liraglutide injection of East China Medicine was accepted, and it was the first company in China to submit a registration application. According to the forecast of Caitong Securities Research Report, there is an extreme shortage of compliant products in the domestic weight loss market, and the compliance market for diet pills is expected to exceed 12 billion yuan in 2025. In the field of autoimmunity, in July 2022, Huadong Medicine submitted the Pre-BLA application of ARCALYST® for CAPS indications to CDE, and it is expected to submit the BLA application in China in the fourth quarter of 2022.

Huadong Pharmaceutical's global medical cosmetology business has 36 products in the field of non-invasive + minimally invasive medical cosmetology, including 22 products that have been listed at home and abroad, and 14 global innovative products under research, and its product portfolio covers non-surgical mainstream medical aesthetic fields such as facial filling, facial cleansing, and thread lifting, and the number of products and coverage fields are in the forefront of the industry.

Industrial microbiology sector, In July 2022, East China and the United States, the People's Government of Gongshu District of Hangzhou Municipality and Zhejiang University of Technology jointly established the East China Institute of Synthetic Biology Industrial Technology, focusing on four major fields: nutrition and pharmaceutical chemicals, medical beauty biology, biomaterials and health sugar substitutes. In August, Huadong Pharmaceutical intends to invest no more than 396 million yuan to control 60% of the equity of Wuhu Huaren Technology Co., Ltd.

From January to September 2022, Huadong Pharmaceutical achieved operating income of 27.86 billion yuan, a year-on-year increase of 7.4%; The net profit of non-attributable parent was 1.90 billion yuan, a year-on-year increase of 7.9%; If East China Ningbo is excluded, the company's operating income increased by 11.2% year-on-year during the reporting period, and the net profit excluding non-attributable parent increased by 9.3% year-on-year.