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IR NEWS LETTER
IR News Letter - Current Status of Clinical Trials and Indications for Rivoceranib (08/29/2019)
Please see the explanations below on various indications of Rivoceranib. The clinical situation below is the most important indicator in determining the value of Rivoceranib and HLB.
1. GC 3rd Line –Phase III clinical trials have been completed and a pre-NDA(New Drug Application) meeting has been requested with the US FDA. The meeting with the US FDA should take a place in mid-October.
2. HCC 1st Line – Rivoceranib + Camrelizumab Combo. Received approval from the US FDA for Phase III clinical trials of ‘Advanced Hepatocellular Carcinoma’ in April this year. The market size for liver cancer is around KRW14 trillion per annum.
3. Adnoid Cystic Carcinoma, ACC, 1st /2nd Line - In order to evaluate the efficacy and safety of Adenoid Cystic Carcinoma(ACC), we received approval from the US FDA for an open label / multicenter clinical phase II trial in 55 patients in 12 hospitals. We can directly apply for NDA upon successful completion of phase II clinical trials.
Above 1 to 3, We have either finished clinical trials(GC 3rd Line) or are in the final clinical stage before NDA.
Therefore, we aim to launch one anticancer drug each year starting with gastric cancer treatment next year.
4. CRC 3rd Line– Rivoceranib + Lonsurf Combo. Received approval from the US FDA for Phase 1b/2 of colorectal cancer phase 3. The market size is around KRW 3 trillion per annum. We will move onto phase 3 upon successful phase 1b/2 clinical trials.
5. GC 2nd Line – Rivoceranib + Taxane Combo. Phase 1 / 2a in progress. As of June, we registered five patients for recruitment of 38 patients.
6. Solid Tumor(Keytruda Combo) - Clinical Phase 1 / 2a. A total of 119 patients with solid carcinoma of the type, including urinary tract cancer, metastatic solid cancer with MSI-H or dMMR biomarkers, and metastatic gastric cancer.
7. Solid Tumor(OPDIVO Combo) - Phase 1 clinical trials are underway for a total of 38 patients with open-label cancer.
** Clinical Status of Apatinib (Rivoceranib)
Jiangsu Hengrui Medicine Co., Ltd. is currently conducting phase 3 clinical trials with 22 indications for Apatinib(Rivoceranib). In addition, eight clinical indications are underway in combination with Camrelizumab. (Source: Morgan Stanley).
Currently, Apatinib(Rivoceranib) is only approved for gastric cancer drug in China, but considering that the success rate of Phase III clinical trials is high, we believe that Apatinib(Rivoceranib) may be sold for ten or more indications in the future in China.
The development of new drugs is particularly difficult because of the long and costly clinical trials to verify the efficacy and safety of candidates, while the success rate is low.
However, we can take the strategy of minimizing trial and error costs by adopting the safest route, following Jiangsu Hengrui’s successful clinical trials.
Our biggest advantage is that the clinical trials done by ‘Jiangsu Hengrui Medicine Co., Ltd.’ is becoming the navigator of new drug development.
HLB will be the first company in Korea to market global anticancer drugs.