CASI Pharmaceuticals is building a portfolio of drugs it intends to produce for Chinese and worldwide markets including Evomela launched in China, an anti-CD19 CAR-T therapy CNCT19, and the anti-CD38 drug CID-103, among others. The goal is to seek approval through new pathways that have opened in the quickly changing Chinese regulatory environment.
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CASI has a multipronged approach to the entrance into the Chinese pharmaceutical market. In August 2019 it launched Evomela (melphalan) in China via the priority review pathway because it was the first approval in the country for any melphalan product. It is also expanding its development pipeline through collaborations, with the recent licensing of an anti-CD38 drug (CID-103), anti-CD19 CAR-T therapy (CNCT19), the novel checkpoint inhibitor BI-1206 and CB-5339, a broad spectrum antineopastic.
Y/E Dec |
Revenue (US$m) |
EBITDA (US$m) |
PBT (US$m) |
EPS (fd) (c) |
P/E (x) |
P/CF (x) |
|---|---|---|---|---|---|---|
| 2019A | 4.1 | (37.5) | (36.5) | (38.74) | N/A | N/A |
| 2020A | 15.1 | (41.4) | (37.9) | (35.04) | N/A | N/A |
| 2021E | 25.8 | (23.1) | (23.2) | (16.96) | N/A | N/A |
| 2022E | 28.8 | (22.8) | (23.8) | (16.54) | N/A | N/A |
Industry outlook
The Chinese regulatory authorities have made a series of substantial changes to their process for drug approval in recent years to improve the availability of new drugs. The Chinese National Medical Products Administration (NMPA, formerly the CFDA) has established new classes of applications for drugs that are previously approved outside of China. Additionally, there is a set of criteria for priority review, which can significantly reduce review times.
Last updated on 21/06/2021Content on CASI Pharmaceuticals
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Healthcare
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| Forecast net debt (US$m) | 110 |
| Forecast gearing ratio (%) | 98 |
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Key management |
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| Wei-Wu He | CEO |
| Alexander Zukiwski | Chief Medical Officer |
| Cynthia Hu | Chief Operating Officer |