Qilu Pharmaceutical Submits First Domestic ANDA for Octreotide Acetate Microspheres, Challenging Novartis' Blockbuster

On January 7, Qilu Pharmaceutical submitted a Class 4 generic drug marketing application for Octreotide Acetate Microspheres for Injection, which is expected to be the first generic version in China. The original developer of this microsphere formulation is Novartis, with sales exceeding 400 million yuan in Chinese public medical institutions in 2020. Changchun Jin Sai Pharmaceutical and Livzon Group have been approved for clinical trials.

Figure 1: The Latest Product Status of Qilu Pharmaceutical's Declaration

Source: CDE Official Website

Figure 2: Sales of Injectable Octreotide Acetate Microspheres (Unit: Ten Thousand Yuan)

Source: Terminal Competition Pattern of Public Medical Institutions in China, Menet

Injectable Octreotide Acetate Microspheres is a long-acting injectable formulation of octreotide that requires only once-a-month administration. It is the preferred medication for treating acromegaly and gastroenteropancreatic neuroendocrine tumors. Novartis' original drug entered the Chinese market in 2003, and so far, there is no generic version available in China. According to data from Menet, in 2020, the sales of the original drug in Chinese public medical institutions—including urban public hospitals, county-level public hospitals, urban community health centers, and township health clinics (referred to as Chinese public medical institutions)—exceeded 400 million yuan. Despite the impact of the pandemic in 2020, the growth rate was still as high as 88%, indicating significant market potential.

Figure 3: Clinical Progress Related to Injectable Octreotide Acetate Microspheres

Source: Menei Network China Drug Clinical Trial Public Database

Changchun Jin Sai Pharmaceutical obtained clinical approval in 2017, and Phase I clinical trials are currently underway; Livzon Group reported production in its 2020 annual report, and subsequently received clinical approval; Qilu Pharmaceutical completed the BE in 2021 and is now applying for marketing approval. Judging from the progress, it is highly likely to secure the first generic drug approval.

In recent years, Qilu Pharmaceutical has vigorously laid out in the field of novel formulations, gradually establishing R&D and production platforms for novel formulations such as microspheres, nanoparticles, orally dissolving films, and soft capsules, achieving the industrialization of multiple scientific research results.

Taking the orally dissolving film pipeline as an example, Qilu Pharmaceutical has already obtained production licenses for Olanzapine Orally Dissolving Film and Montelukast Sodium Orally Dissolving Film. The Aripiprazole Orally Dissolving Film, Tadalafil Orally Dissolving Film, and Memantine Hydrochloride Orally Dissolving Film are currently under production submission. Additionally, the clinical trial approvals for Escitalopram Oxalate Orally Dissolving Film, Risperidone Orally Dissolving Film, and Vardenafil Hydrochloride Orally Dissolving Film have long been in their possession. This submission of the injectable Octreotide Acetate Microspheres for marketing represents a solid step forward in the company's microsphere formulation pipeline.

Source: MiNeiNet Database, CDE Official Website

Clinical data statistics are as of January 6th. If there are any errors or omissions, please kindly point them out.