Date：2018.05.14

2. The Timeline : NA

3. Oneness submitted New Drug Application to TFDA with its ON101 cream (WH-1) dated May 14th, 2017

(1) Investigational Product Name or Code : ON101 cream (WH-1)

(2) Indication : To treat diabetic foot ulcer

(3) Forecast with R&D Activity : 

i. To perform the phase 3 MRCT clinical trial in US, China and Taiwan

ii. To submit TFDA with NDA review

(4) Current R&D Activity : 

i. To execute phase 3 MRCT in US, China and Taiwan

ii. To submit Taiwan NDA based on the interim analysis result

A. Status (Submission/Approval/Dis-Approval) : To submit TFDA with NDA review

B. Risk and Actions : Not applicable

C. The business operation strategy : Not applicable

D. The accumulated R&D expenditure : Considering the market strategy and investor protection, the information would not be disclosed at this moment.

(5) R&D Activity in Next Stage :

A. It was forecasted to submit EMA with the same phase 3 MRCT protocol (ON101CLCT04) which was approved by US FDA in early 2018. This phase 3 MRCT trial will be performed with Caucasian data to shorten the global market approval.

a. The estimated completed timeline : the phase 3 MRCT trial with Chinese (ON101CLCT02) will be performed since year 2018 and be completed by end of year 2019. The progress with the phase 3 MRCT trial with Caucasian will be depended on the review progress of US FDA and EMA.

b. The estimated obligation : No

(6) Market Outlook : The diabetic patient number was forecasted up to 629 million in year 2045 as which was increased from 425 million in year 2017. 12 to 15% of the diabetic patients suffered with foot ulcer and even amputation in the worst case, and the 5-year survival post-amputation would be around 50%. As far, the diabetic foot ulcer remains to be an unmet medical need, and the standard treatment including plastic surgery, dressing, antibiotic sterile products yet present an acceptable efficacy. 

 (7) The investors were suggested to make the best judgment regarding the potential risk as the new drug development would take a long period, and high investment would not guarantee the success.

 4. Others :

(1) The statement was announced on the basis of OTC announcement “上(興)櫃公司重大訊息發布應注意事項參考問答集”. 

(2) ON101(WH-1) was granted with two phase 3 trials approvals. The first phase 3 MRCT trial with Chinese (ON101CLCT02) is ongoing in China and Taiwan, and the Taiwan FDA NDA has been submitted on May 14th, 2018 based on the interim analysis result. Oneness will submit the China NDA based on the study outcome of this phase 3 MRCT trial. In addition, the phase 3 MRCT trial with Caucasian (ON101CLCT04) will aim for the market of the Caucasian population, and the global market approval will be based on these two phase 3 pivotal trial result.

(3) Oneness kicked off to build the NanChou factory, and it aims to manufacture 50 million tubes of ON101 cream (WH-1)  once the PICS/GMP certification was granted in year 2018.