Neovacs Confirms Filing of Authorization Request for PXT3003 in China
The biopharmaceutical company confirms that the Chinese laboratory Tasly filed an application in April 2025 for marketing authorization for PXT3003, a drug candidate initially developed by Pharnext to treat Charcot-Marie-Tooth disease type 1A. This step could impact the assets held by Neovacs as part of the judicial liquidation of Pharnext.
Filing Details
Neovacs stated in a press release that the Chinese pharmaceutical laboratory Tasly submitted on April 11, 2025, an application for marketing authorization of PXT3003 to the Chinese Center for Drug Evaluation. This drug candidate aims to treat Charcot-Marie-Tooth disease type 1A, a rare and disabling hereditary peripheral neuropathy. PXT3003 was developed by the company Pharnext, now in judicial liquidation, which had granted a license for the exploitation rights for China to a joint venture owned 65% by Tasly. Neovacs has previously communicated about this situation in April 2025. According to the company, the shares in the joint venture are not part of the assets that could revert to it as part of the liquidation of Pharnext.
Potential Impact on Assets
According to the press release, a marketing authorization in China could impact the assets held by Neovacs. The company indicates that this would require signing a licensing agreement with a partner capable of exploiting the Chinese authorization to support authorization requests in other regions, particularly in Europe and the United States. The company also specifies that such a partner could market PXT3003 in countries where Chinese authorizations are recognized. Neovacs mentions that this type of agreement could include milestone payments and a progressive royalty rate ranging from 8% to 15% of net sales in the long term, similar to proposals made to Pharnext before the publication of the PREMIER clinical trial results.
Uncertainties and Future Plans
The company emphasizes that it has no certainty about the outcome of this authorization process. Neovacs has recorded a provision equivalent to 100% of the value of its claim against Pharnext since June 30, 2024. According to the press release, a Management Committee will meet soon to study this opportunity. The company indicates that it will inform the market of its potential conclusions. Neovacs presents itself as a preclinical stage biopharmaceutical company developing therapies for inflammatory and autoimmune diseases, and also conducts investment activities in innovative companies in biotechnology and medtech.
