Recently, ADC-related product information has attracted much attention, and Rongchang Biologics, which has the first independently developed ADC innovative drug in China, has also attracted attention, and Rongchang's product updates have been frequent recently.
Today, Insight sorted out Rongchang Biotech’s pipeline.
2 innovative drugs are under development, and ADCs are the main track
According to the Insight database, Rongchang Biotech currently has a total of 22 products, of which 12 are ADCs with the highest proportion, about 55%. Judging from the progress of research and development, 7 products have entered the clinical stage and 2 have been approved for marketing.
Rongchang Biotech’s 22 products under development have the highest progress in the world
From: Insight database
According to the Insight database, the top three ADC targets in the world are HER2 (63 models), TROP2 (17 models) and EGFR (16 models). Of course, Rongchang Biotech also has plans for popular targets. Its first commercial ADC target is HER2. In addition, it also has plans for 2 EGFRs.
Rongchang Bio ADC target layout
From: Insight database
HER2ADC
Indications Take the wrong side - Urothelial carcinoma
The first-tier vedicitomab /RC48 is a HER2 ADC. According to the Insight database, vedicitomab was first approved for gastric cancer indications in China in August 2020. Since then, it has been used in many cancers including urothelial cancer, melanoma, ovarian epithelial cancer, etc. Relevant clinical trials are carried out in all species. Among them, urothelial carcinoma has attracted much attention.
Vedicitumab global research progress Gantt chart
From: Insight database
In 2021, vedicitumab was included in the Chinese Clinical Oncology (CSCO) guidelines, establishing its role in HER2 overexpression (Immune Group The treatment status of urothelial carcinoma if the chemical test result is 2+ or 3+). In January 2022, vedicitomab was approved for marketing in China for urothelial cancer.
Gantt chart of the global development progress of vedicitomab in urothelial cancer
From: Insight database
At this year’s ASCO meeting, Rongchang Biotech announced in poster form the efficacy of RC48 in HER2-negative and HER2-overexpressing locally advanced patients. or clinical data in metastatic urothelial carcinoma, as well as preliminary results from a Phase Ib/II study in combination with toripalimab in locally advanced/metastatic urothelial carcinoma (RC48-C014 trial, NCT04264936). Overall, RC48, whether used as a single agent or in combination with PD-1, shows excellent efficacy and controllable safety. The results of the
study show that patients with urothelial cancer can benefit from combined PD-1 treatment regardless of the number of treatment lines and the expression status of HER2 and PD-L1. In patients with mUC, the cORR was 71.8%. As the expression of HER2 or PD-L1 increases, the ORR value increases. In the Ib/Phase II trial, the cORR in treatment-naive mUC patients was 73.9% (17/23).
Based on this, Rongchang Biotech has launched a phase 3 clinical study of RC48 combined with toripalimab versus platinum-containing standard chemotherapy for first-line mUC patients in April this year (registration number: NCT05302284).
NCT05302284 Clinical trial
from: Insight database
Efficacy of vedicitumab in patients with HER2-negative advanced urothelial carcinoma, specifically IHC 1+ patients, with an overall median OS of 16.4 months. Most treatment-related adverse events were grade 1-2, similar to previous RC48 monotherapy studies. RC48 adverse reactions are tolerable and controllable. RC48 is safe and effective in HER2-negative advanced urothelial cancer.
Additionally, vedicitomab significantly improved response rates in patients with HER2-overexpressing (IHC2+ or 3+) LA/mUC who had received at least one prior systemic chemotherapy and showed a long-term survival benefit with a manageable safety profile. . Similar efficacy responses were observed in prespecified subgroups, such as patients previously treated with I-O drugs and patients with visceral metastases.(Clinical trial registration number: NCT03507166, NCT03809013)
Previously, in August 2021, Rongchang Biotechnology licensed vedicitomab to the American company Seagen (Seagen) for a total price of US$2.6 billion. It is currently in the United States Conducting a phase II clinical trial for urothelial cancer (registration number: NCT04879329).
Vedicitomab pharmaceutical transaction
From: Insight database
Compared with breast cancer , , the current market competition for urothelial cell cancer is relatively gentle, and it can be regarded as a blue ocean market, with more promising prospects.
According to Frost & Sullivan data, there will be approximately 516,000 new cases of urothelial cancer in the world in 2020, and it is expected to reach approximately 586,000 cases in 2025, with a compound annual growth rate of 2.6% from 2020 to 2025; In China, it is expected to reach approximately 91,000 cases in 2025, with a compound annual growth rate of 3.4% from 2020 to 2025.
From the perspective of drug market size, according to Frost & Sullivan data, the global market size of urothelial cancer treatment drugs is expected to increase to US$6.9 billion in 2025, with a compound annual growth rate of 21.2% from 2020 to 2025; In China, it is expected to increase to US$900 million in 2025, with a compound annual growth rate of 39.7% from 2020 to 2025.
In the field of urothelial cancer, vedicitomab is the first and only HER2 ADC approved for marketing.
According to the Insight database, there are currently 6 HER2 ADCs in the world that are conducting clinical research on urothelial cancer. In China, in addition to Vidicitomab, there are also A166 from Colombote and Hangzhou Duoxi Biotech. DX126-262 and Meyake's MRG002 have entered the clinical stage.
Among them, Meyake is currently conducting an open, single-arm, multi-center phase II clinical trial of MRG002 in the treatment of HER2-positive unresectable locally advanced or metastatic urothelial cancer that has received at least first-line systemic chemotherapy (registration number: CTR20210236).
CTR20210236 Clinical trial
From: Insight database
Differentiated layout of targets
On the one hand, Rongchang Biotech has laid out the popular targets HER2 and EGFR. In addition, it has also differentiated its layout of multiple targets such as CD19, cMET, Claudin 18.2.
Rongchang Bio ADC target layout
From: Insight database
, CD19 ADC: RC58
Rongchang Bio has laid out CD19 ADC, which are currently in the preclinical research stage.
Rongchang’s 3 CD19 ADCs
come from: Insight database
According to the Insight database, there are currently 12 CD19-targeting ADCs under research in the world, of which 7 have entered the clinical stage. Currently, only 1, Loncastuximab tesirine, has been approved for marketing.
Global targeting CD19 ADC layout
From: Insight database
In China, except for Loncastuximab tesirine, which is undergoing phase III clinical trials, only Rongchang Biological's RC58 has certain competitive advantages.
, cMET ADC: RC108
RC108 is Rongchang’s third ADC drug to enter clinical research, targeting c-Met-positive advanced solid tumors. c-Met is a receptor tyrosine kinase , which can activate a variety of different cell signaling pathways after binding to its ligand hepatocyte growth factor , including cell signals related to proliferation, movement, migration and invasion. path. c-Met is a well-characterized oncogene associated with poor prognosis in many types of solid tumors.
Currently, phase I clinical trials for c-Met-positive advanced solid tumors have been launched in China (registration numbers: CTR20202395, NCT04617314).
RC108 Global Gantt chart of research progress
From: Insight database
According to the Insight database, there are currently only 3 ADCs targeting MET in research in China. The fastest progressing one is AbbVie 's Telisotuzumab Vedotin, while Heng The two domestic products developed by Rui and Rongchang are at similar progress and both are in the Phase I clinical stage.
There are 3 ADCs under development in China that target MET.
From: Insight database
, Claudin 18.2 ADC: RC118
RC118 is an ADC targeting Claudin18.2. Currently, a study is being carried out to use RC118 for injection in locally advanced patients with positive Claudin 18.2 expression. Phase I/II clinical study in patients with resected or metastatic malignant solid tumors (registration numbers: CTR20212857, NCT05205850). This is also the fourth ADC therapy developed by Rongchang Biologics, following RC48 (vedicitomab), RC88, and RC108.
RC118 global research progress Gantt chart
From: Insight database
Currently, according to the Insight database, there are 6 ADCs targeting Claudin18.2 in China. Among them, the products of Rongchang Biological and Lixin Pharmaceuticals are making the fastest progress, and both The progress of both companies is similar, and they are all conducting Phase I/II clinical studies. RC118 has the potential to become the first domestically produced model.
There are 6 ADCs targeting Claudin18.2 under development in China
From: Insight database
Increase investment in R&D to facilitate multi-pipeline layout
Rongchang Biotech has been in a state of loss in recent years, until Q1 this year achieved operating income of 150 million, exceeding last year Annual sales revenue. However, even in the previous state of continuous losses, Rongchang Biotech has not stopped increasing investment in research and development. The compound annual growth rate of 's R&D investment from 2018 to 2020 is as high as 46.70% . In 2021, R&D expenses increased by 52.63%, reaching 711 million yuan; and the previously disclosed quarterly report showed that 's R&D investment in Q1 this year was 218 million yuan, a year-on-year increase Up to 60.29%.
Rongchang Biotech currently has 3 major technology platforms: antibody and fusion protein platform, ADC platform and dual antibody platform. means that in addition to ADC, Rongchang Biotech is also laying out more pipelines. There are currently 5 dual-antibody products under development. Anti-and 3 antibody fusion proteins.
Category distribution of Rongchang Biotech's products under development
From: Insight database
The three antibody fusion proteins are in the preclinical, clinical phase II and approved marketing stages respectively. From the perspective of indication fields, these three products cover the three major fields of autoimmunity, anti-tumor and ophthalmology, which perfectly fit the indication layout direction of Rongchang Biological in the entire R&D pipeline.
Rongchang Biotech’s 3 antibody fusion proteins
From: Insight database
Among them, Tatarcept (RC18), a new star in the field of autoimmunity, is Rongchang Biotech’s first commercial product. It was conditionally approved for marketing by NMPA in March 2021. , for the treatment of systemic lupus erythematosus (SLE).
Currently, Rongchang is actively promoting the expansion of the indications of Tatacept in IgA nephropathy, Sjogren's syndrome (SS), neuromyelitis optica spectrum disorder (NMOSD) and other six other autoimmune diseases.
Gantt chart of global R&D progress of Tatacept
From: Insight database
RC28 is currently in the clinical stage. This is a fusion protein targeting vascular endothelial growth factor (VEGF)/fibroblast growth factor (FGF). Rongchang is currently evaluating the efficacy of RC28 on several eye diseases, including wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR). It is currently in Phase II clinical trials.
RC28 Global R&D Progress Gantt Chart
From: Insight Database
Rongchang, which ranks second in terms of number of product categories, has a total of 5 products under development, all of which are currently in the preclinical stage. The treatment areas include tumors and ophthalmic diseases.
Rongchang Biotech has 5 dual-antibody products
From: Insight database
In addition, Rongchang Biotech also has 1 monoclonal antibody, RC98, which is currently undergoing clinical trials for urothelial cancer, lung cancer and other cancer types.
Overall, Rongchang Biologics has deployed 2 innovative drugs in the fields of tumors, autoimmunity and ophthalmic diseases. focuses on ADCs. At the same time, it continues to increase investment in research and development and deploy pipelines such as dual antibodies and antibody fusion proteins. . In the ADC field, on the one hand, the popular target HER2 is deployed, and at the same time, multiple targets such as CD19, cMET, and Claudin 18.2 are differentiated.As for HER2 ADC, it has a differentiated layout in terms of indications. The transfer of overseas rights and interests of this product for a total price of US$2.6 billion also fully proves Rongchang Biological's research and development capabilities.
This article comes from Insight database
