The first domestic ADC listing in China will be held!

On August 15th, under the epidemic situation, Rongchang Bio-Vidicuzumab Gastric Cancer Indications (trade name: Aidixi®) will be launched in the three main venues in Beijing and Shanghai, as well as in Xi’an, Nanjing, and Shenyang.

The three main venues in Beijing and Shanghai are synchronized with 16 branch venues across the country

Vidicuzumab was approved by the National Food and Drug Administration on June 8 this year for the treatment of HER2 overexpression patients with locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) who have received at least two systemic chemotherapy

Vidicuzumab fills the gap in the treatment of HER2 overexpressing gastric cancer

Gastric cancer is the second largest cancer in China.

The breakthrough in the treatment of HER2+ advanced gastric cancer by vedixituzumab is related to its very characteristic drug molecular structure.

The results of an open-label, multi-center, single-arm Phase II study (NCT03556345) of vedicitumumab in the treatment of locally advanced or metastatic gastric cancer with HER2 overexpression led by Professor Lin Shen, announced by the ASCO2020 conference (NCT03556345) showed that 127 cases have been accepted in the past For patients with HER2 overexpression (including ICH3+, IHC2+/FISH+, and IHC2+/FISH-) who have undergone 2-line or more systemic chemotherapy, patients with advanced gastric cancer (including gastroesophageal junction adenocarcinoma), the objective response rate assessed by IRC was 24.

Professor Shen Lin from Peking University Cancer Hospital said at the launch meeting: “As China’s first approved national original ADC, the listing of vedicitumumab has multiple meanings.

With continuous international breakthroughs, vedicitumumab attracts global attention

The listing of gastric cancer indications in China is a major milestone in the development of a new drug for vedicitumumab

As early as at the ASCO conference in 2019, Rongchang Bio-Bio announced for the first time the clinical data of Vidicuzumab on HER2-expressing urothelial cancer subjects who received multi-line therapy, which won global attention

On the eve of the launch event, Rongchang Biotech announced on August 9th that it had reached a global exclusive licensing cooperation agreement with the global ADC drug leader Seagen on vedicitumumab, which will obtain a total of up to 2.

This transaction, which refreshed the record of the amount of overseas authorized cooperation for a single-variety of Chinese pharmaceutical companies, has brought Vidicuzumab and Rongchang Biotech into the global spotlight once again

In terms of gastric cancer indications, in addition to Japan and Singapore, which have higher incidences, Seagen is worth exploring.

Among other indications, urothelial cancer is the most anticipated for vedicitumumab

With HER2+ gastric cancer, urothelial cancer, breast cancer and other major indications gradually entering the harvest period, Rongchang Bio is still exploring the efficacy of Vidicuzumab in other cancers and patients with low or no HER2 expression.

The completed or ongoing clinical trials of Aidixi

In short, Rongchang Biotech has made many milestone international breakthroughs in vedicitumumab.

Comprehensive improvement in comprehensive strength, Rongchang Biotech transforms into an international biopharmaceutical company

With the commercialization of Vidicuzumab, Rongchang Bio-pharmaceuticals has become one of the few domestic biopharmaceutical companies that can successfully launch more than two original innovative drugs, fully demonstrating its own innovative drug research and development capabilities

On August 10th, Rongchang Biotech also announced that another blockbuster new drug, Taitacept has been used in the treatment of IgA nephropathy to achieve key progress, and a domestic phase II clinical study has reached the primary endpoint

Tatacept was previously approved by the NMPA for the treatment of systemic lupus erythematosus (SLE) on March 11 this year.
As the world's first dual-targeted SLE therapy, it has greatly met the clinical needs of patients and has been in this disease field for more than 60 years.
A handful of major breakthroughs
.
IgA nephropathy is a glomerulonephritis caused by immune complexes.
Patients will eventually develop renal failure or end-stage renal disease.
Up to 50% of patients require dialysis or kidney transplantation
.
To date, there is no specific therapy or biological drug approved for the treatment of IgA nephropathy in the world
.
Taltazep has been approved to carry out phase III clinical trials for SLE indications in the United States, and phase I studies have been exempted for IgA nephropathy indications to directly carry out phase II clinical trials
.
Aiming at the huge global clinical unmet needs, Rongchang Bio is expected to bring good news to many patients with SLE and IgA nephropathy
.

An overview of Rongchang's other product pipelines is also worth looking forward to
.
Especially in the ADC field, Rongchang Bio has built an industry-leading end-to-end ADC platform, covering the discovery/optimization, process development, analytical development and production of new ADC therapeutic drugs
.
At present, Rongchang Biologics has used this platform to develop 4 ADC drug candidates.
In addition to vedicitumumab, RC88 (mesothelin ADC), RC108 (c-Met ADC), and RC118 (Claudin18.
2 ADC) are in phase I Clinical development stage
.
Another VEGFR/FGFR dual target fusion protein product RC28, which is intended to be used in multiple ophthalmic diseases, has entered Phase II clinical trials
.

On the whole, within 13 years of the company’s establishment, Rongchang Biopharmaceuticals have commercialized their two internationally leading original and innovative drugs, tatacept and vedicitumumab, in China, and they have been put into use along with the industrialization base.
, The formation of a commercialization team is ready to go, international development breakthroughs continue, BD transactions with leading national companies to open up the international market space, Rongchang Bio's strength has been comprehensively improved in the past two years, is currently accumulating efforts to complete the biotech from China The company's transformation into an international biopharmaceutical company
.