Hengrui's First Orally Disintegrating Film Approved! A 1Bn-RMB Market Set for Reshuffle

ByUnexpired

On February 9, the NMPA official website released the latest information on approved drugs. Ondansetron Oral Soluble Film and Tadalafil Oral Soluble Film were approved on the same day. So far, there are four domestically produced oral soluble film products approved for marketing in China. Tadalafil Oral Soluble Film is the third oral soluble film product approved for Qilu Pharmaceutical, while Ondansetron Oral Soluble Film is the first oral soluble film product approved for Hengrui Pharma.

Figure 1: Information on the latest approved products

Source: NMPA official website

Figure 2: Previously approved orally dissolving films produced in China

Source: NMPA official website

Data shows that the first domestically produced oral soluble film in China was approved for marketing in 2020, with Hansoh obtaining the first approval for Olanzapine Oral Soluble Film in China. Subsequently, Qilu Pharmaceutical obtained approvals for Olanzapine Oral Soluble Film and Montelukast Sodium Oral Soluble Film in 2021. The recently approved Tadalafil Oral Soluble Film is Qilu's third approved oral soluble film product. Currently, the company has applications under review for Memantine Hydrochloride Oral Soluble Film and Aripiprazole Oral Soluble Film.

Figure 3: Sales of Ondansetron (Unit: Ten Thousand Yuan)

Source: Terminal Competition Pattern of Public Medical Institutions in China, from the MiNe Network

Ondansetron is a selective 5-HT3 receptor antagonist, which is mainly used clinically as an antiemetic for nausea and vomiting caused by cytotoxic drug chemotherapy and radiotherapy. It can also be used for the prevention and treatment of postoperative nausea and vomiting. Data from MiNe Network shows that in 2020, the sales scale of ondansetron in Chinese public medical institutions (including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers) exceeded 1 billion yuan, with a growth rate of up to 38.94% in the first half of 2021. Currently, the popular dosage forms on the market include injections and tablets. Qilu Pharmaceutical is the leading company in this field, with a market share of up to 67.18% in the first half of 2021. Hengrui Pharma's orally dissolving film of ondansetron is the first of its kind in China.

Table 1: Status of Hengrui Pharma's Orally Disintegrating Film Submissions

Source: MNI 2.0 MED China Drug Evaluation Database

Ondansetron Oral Soluble Film is Hengrui Pharma's first approved and marketed oral soluble film product, filed as a Category 3 generic drug. It is the first generic in China to receive approval and pass the quality evaluation. Currently, the marketing application for Tadalafil Oral Soluble Film, jointly filed by Hengrui and Hansoh, is under review and has the potential to become the second domestically produced product of its kind in China. Additionally, Hengrui previously received clinical approval for Zolmitriptan Oral Soluble Film and Entecavir Oral Soluble Film, showing its growing commitment to the oral soluble film field.