Recently, Jiangsu Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as "Hengrui Pharmaceutical") announced that Hengrui Pharmaceutical received a certification letter from the U.S. Food and Drug Administration (hereinafter referred to as "FDA"), and the company's project SHR-A2009 for injection was granted fast track designation (FTD) by the U.S. FDA.
Fast Track Designation is a designation granted by the U.S. FDA to a drug under development to facilitate the development of new drugs for the treatment of serious diseases and to address unmet clinical needs. After the drug obtains FTD, the new drug development company will have more opportunities to communicate with the FDA during the subsequent drug development and review process.
In recent years, a number of innovative drugs developed by Chinese companies have been granted breakthrough therapy designation or fast-track status by the FDA, including innovative therapies with different mechanisms of action such as anti-PD-1 monoclonal antibodies, CSF-1R inhibitors, BTK inhibitors, and FAK inhibitors.
Hengrui Pharmaceutical's innovative anti-cancer drug has obtained FDA fast-track qualification
According to Hengrui Pharmaceutical's announcement, the proposed indication of SHR-A2009 for injection is for the treatment of metastatic non-small cell lung cancer with EGFR mutations that have progressed after third-generation EGFR tyrosine kinase inhibitors and platinum-containing chemotherapy.
SHR-A2009 for injection is an antibody-drug conjugate targeting HER3 independently developed by the company, which can specifically bind HER3 on the surface of tumor cells, and then be endocytosed into cells and transported to lysosomes, where free toxins are released by water and killed tumor cells. SHR-A2009 entered clinical studies in 2021 and has now advanced to Phase II clinical trials, and its international multi-center Phase I clinical studies for the treatment of solid tumors are being carried out in 16 centers in China, Japan and South Korea. The preliminary results of the study were presented in the short oral presentation session of the 2023 ESMO, showing good anti-tumor activity, safety and pharmacokinetic characteristics. No similar drug has been approved for marketing in the world. Up to now, the cumulative R&D expenditure of about 49.92 million yuan has been invested in the projects related to SHR-A2009 for injection.
In this regard, Dr. Jiang Ningjun, Director and Chief Strategy Officer of Hengrui Pharmaceutical, said: "SHR-A2009 is the first innovative drug in Hengrui's history to obtain Fast Track Designation from the US FDA. This title will help accelerate the use of SHR-A2009 in the treatment of major diseases and solve unmet clinical needs, and is also a recognition of the advanced technology and clinical development level of Hengrui ADC platform. Hengrui will continue to strengthen its internationalization strategy to allow more and better innovative treatment options to benefit patients around the world as soon as possible. ”
It is worth noting that the number of new cases and deaths of lung cancer ranks first among malignant tumors in mainland China. Non-small cell lung cancer (NSCLC) accounts for about 85% of all newly diagnosed lung cancer cases. There is a huge clinical need for the treatment of patients with EGFR-mutated advanced NSCLC who have failed EGFR-TKI and platinum-based chemotherapy.
Hengrui Pharmaceutical pointed out that SHR-A2009 for injection is an antibody-drug conjugate targeting HER3 independently developed by Hengrui Pharmaceutical, which can specifically bind to HER3 on the surface of tumor cells, and then be endocytosed into cells and transported to lysosomes, which release free toxins and kill tumor cells by hydrolysis. No similar drug has been approved for marketing in the world.
The reporter learned from Hengrui Pharmaceutical that up to now, Hengrui has carried out a total of 3 clinical studies of SHR-A2009, all of which are underway, to explore the safety, tolerability, pharmacokinetics and efficacy of SHR-A2009 monotherapy or combination therapy in patients with advanced solid tumors. In the first-in-human trial of SHR-A2009-I-101, patients with NSCLC showed promising efficacy and safety.
In terms of ADC drug layout, Hengrui Pharmaceutical has 9 new and differentiated ADC molecules successfully approved for clinical trials, and a number of innovative drug products have been deployed in various solid tumor treatment fields, in order to bring more treatment options to patients.
ADC drugs are frequently cashed out to the sea
2023 is considered to be the first year for innovative drugs to go overseas. Many brokerages believe that the quality of R&D of domestic innovative drugs has been continuously improved, and the value of domestic new drugs has been fully recognized by multinational pharmaceutical companies.
According to the research report of CITIC Securities, domestic companies' innovative drugs/biosimilars will begin to set off a small upsurge in going overseas (FDA approval for marketing/external authorization) in the second half of 2023, and are expected to gradually enter the key milestone cashing period for commercialization/cooperation of overseas blockbuster varieties in 2024.
According to the reporter's incomplete combing, a number of innovative drugs developed by Chinese companies have been granted breakthrough therapy designation or fast-track designation by the FDA, covering different targets and innovative therapies, such as anti-PD-1 monoclonal antibodies, CSF-1R inhibitors, etc.
What is particularly outstanding is that this year, ADC has frequently gone overseas to cash.
ADCs combine precisely targeted monoclonal antibodies with small molecule drugs with cell-killing toxicity to achieve both efficacy and targeting, and the monotherapy form is mainly used in the end-line treatment of oncology, which can overcome the limitations of traditional chemotherapy and targeted therapy.
According to the analysis of Guolian Securities, ADC has a good matching degree and synergy. For overseas large pharmaceutical companies, ADC products have a high strategic fit with their own pipeline layout, which can fill the gap in the product portfolio, and can save their own time and cost to a large extent through license in, so as to win a broad market space in the future with low investment.
Frost & Sullivan expects the global ADC drug market to grow from $11.4 billion to $64.7 billion from 2023 to 2030, with a CAGR of 28.1%.
In addition to Hengrui, Henlius (2696. HK) has also previously received Fast Track Designation from the FDA. On December 27, 2023, Henlius announced that HLX42, an EGFR-targeted ADC for injection developed by the Company, has been granted FTD by the FDA for the treatment of EGFR-mutated advanced/metastatic non-small cell lung cancer (NSCLC) that has progressed after treatment with third-generation EGFR tyrosine kinase inhibitors.
MRG003, an EGFR-targeted ADC product independently developed by Lepu Biopharma for the treatment of advanced nasopharyngeal carcinoma (NPC), has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA).
Written by: Nandu reporter Wu Yueming