Upgraded patent disputes with Platinum and Baiaosaitu; Rongchang Biotech’s Taitacept has been recognized as an orphan drug by the European Union

June 19, 2025  Source: drugdu 54

 

NO.1 and Platinum, Baiaosaitu Patent Dispute Escalation

On the 16th, Hebo Pharmaceutical announced the latest progress of its core patent protection action to the public. The China National Intellectual Property Administration made an examination decision on June 5, 2025 to maintain the patent right of "binding molecule" with platinum medicine. The patent involves the method of preparing whole human heavy chain only antibody (HCAb) using transgenic animals, and this decision is made in response to the request for invalidation made by BIOSAITO (Beijing) Medical Technology Co., Ltd.

Comment: From the previous actions, it is clear that Hebo Pharmaceutical regards this patent protection as a key measure to safeguard its core assets. The "binding molecule" patent of Platinum Pharmaceuticals is its Harbour Mice ® The core of the platform, which has established partnerships with multiple well-known pharmaceutical companies worldwide, has significant commercial value.

NO.2 Yunnan Baiyao JZ-14 Capsules Obtained Clinical Trial Approval

JZ-14 capsule is a chemical class 1 innovative drug independently developed by Zhengwu Technology, a subsidiary of Yunnan Baiyao Holdings. It is a small molecule immunomodulatory agent of First in Class. JZ-14 can selectively bind to specific protein targets, inhibit downstream AKT/NF - κ B signaling pathways, and exhibit significant immune regulation and anti proliferative activity in ulcerative colitis and various tumor models.

Comment: If JZ-14 capsules are successfully clinically transformed, they can not only fill the gap in the field of immune regulation, but also expand Yunnan Baiyao's layout in the field of chemical medicine innovation. However, attention should be paid to its clinical safety and efficacy verification, as well as its future competitive situation with biopharmaceuticals.

NO.3 Rongchang Biotech Taitacept has been recognized as an orphan drug by the European Union

Rongchang Biotechnology's product, Taitai Xipu (trade name: Taiai) ®, R&D code: RC18) has been granted Orphan Drug Designation (ODD) by the European Commission (EC) for the treatment of myasthenia gravis.

Comment: Based on the orphan drug qualification granted by the European Commission, Taitacept will enjoy a series of policy support in the EU, including scientific advice on research and development plans, partial fee reductions, preferential marketing application fees, and a ten-year market exclusivity period after approval. This will greatly promote the development process of Taitacept's indications for myasthenia gravis in the EU.

NO.4 Merck long-acting RSV monoclonal antibody to be included in priority review in China

According to the official website of CDE (Center for Drug Evaluation of the National Medical Products Administration), Merck's Clesrovimab (MK-1654) injection is scheduled to be included in the priority review for marketing application, with indications for preventing lower respiratory tract infections caused by respiratory syncytial virus (RSV) in newborns and infants who are about to enter or born in the first RSV epidemic season.

Comment: Merck's Clesrovimab long-lasting protective properties may change the existing RSV prevention pattern, but attention should be paid to differentiated competition and pricing strategies with vaccines.

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