Competition Heats Up for First Generic Omadacycline in China as Domestic Pharma Collaboration Emerges as Key Strategy

On December 4, according to the CDE official website,Hainan Guangshengyu PharmaceuticalAndHainan Lingkang PharmaceuticalThe Marketing Application for Omadacycline Tosylate for Injection, a Generic Drug of Chemical Category 4, Jointly Submitted, Has Been Accepted. To date, no generic version of this drug has been approved for marketing in China.

_{Screenshot source: CDE}

Omadacycline Tosylate byParatek PharmaceuticalCarefully developed, it belongs to the 30S subunit inhibitors and is an innovative member of the tetracycline family. In 2018, this drug was successfully approved for marketing in the United States, injecting new vitality into the field of antibacterial treatment. This variety mainly targets community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), and with its unique mechanism of action and good efficacy, it is regarded as a "powerful tool" to address the current severe antibiotic resistance crisis.MoxEntropy Medical DatabaseIt shows that this product achieved explosive sales growth in 2024, with total sales in the all-terminal hospital market approaching 300 million yuan, a year-on-year increase of 128.84%. In the first half of 2025, sales reached nearly 200 million yuan, a year-on-year increase of 44.08%, indicating promising market potential.

_{Screenshot source: Mosan Pharmaceuticals All-Terminal Hospital Sales Database}

Omadacycline Tosylate Meets Urgent Clinical Needs in China and Was Included in the "List of Overseas New Drugs Urgently Needed Clinically (Second Batch)." In March 2018, the drug was applied for clinical trials for the first time and entered Phase III clinical trials in December. In 2024, the injectable form of the drug was successfully included in the Class B Medical Insurance Catalogue through negotiation, which further improved the accessibility of the drug and reduced the economic burden on patients.

_{Screenshot source: Mesentech Global Drug Research and Development Database}

Currently, Omadacycline Tosylate for Injection isZai LabExclusive variety. December 2021,Zai LabApproved for production in China through a new drug application, enjoying a clear period of exclusivity红利 in the Chinese market due to this first-mover advantage.

_{Screenshot source: Mosan Medicine China Drug Approval Database}

However, the monopolistic market pattern is not set in stone. In June this year,Qilu PharmaceuticalFire the "first shot" of the generic application, and thereafter, numerous pharmaceutical companies followed suit. As of now,North China Pharmaceutical、Kelon PharmaceuticalTen pharmaceutical companies, including Zai Lab and Qilu Pharmaceutical, have submitted Class 4 generic drug applications, all of which are currently under review.

_{Screenshot source: Mose Pharmaceuticals China Drug Evaluation Database}

This time,Hainan Guangshengyu PharmaceuticalAndHainan Lingkang PharmaceuticalThe joint entry has intensified the competition for the first generic drug. The first generic drug can not only gain a competitive edge in the market and achieve considerable economic benefits, but also enhance the brand influence and industry status of enterprises. Therefore, this contest for the first generic drug has drawn much attention, and who will secure the rights to the first generic drug has become a focal point eagerly anticipated by both inside and outside the industry.

       Title: The Race for the First Generic of Innovative Antibiotic Omadacycline Heats Up, Collaborative R&D Model by Chinese Pharmaceutical Companies Becomes the Key to Breakthrough!