Qilu Pharmaceutical Secures Approval for Two Key Generic Drugs: Nab-Paclitaxel for Injection and Tadalafil Tablets

Source: PharmCube Info

Original: Vernacular Chinese

On November 6, Qilu Pharmaceutical received marketing approval for two blockbuster generic drugs: Paclitaxel for Injection (Albumin-bound) and Tadalafil Tablets. As both were registered under Category 4, their approval is deemed equivalent to passing the consistency evaluation. Consequently, the number of domestic generic manufacturers that have passed the consistency evaluation for each of these two major products has reached three.

I. Paclitaxel for Injection (Albumin-Bound)

Albumin-bound paclitaxel, developed by Abraxis BioScience in the United States, is a novel formulation of paclitaxel bound to albumin. It overcomes the drawbacks of conventional paclitaxel, such as poor water solubility, low efficacy, and significant side effects. Approved by the FDA in January 2005 for the treatment of breast cancer under the brand name Abraxane, it subsequently received approval for the treatment of lung cancer and pancreatic cancer. In 2010, Celgene acquired Abraxis for an upfront payment of $2.9 billion, thereby adding Abraxane to its portfolio. In 2018, global sales of Abraxane amounted to approximately $1.062 billion.

Abraxane was approved in China on June 10, 2008. BeiGene obtained the commercial rights for Abraxane in China through a transaction with Celgene in July 2017. Qilu Pharmaceutical is the third company in China to obtain marketing approval for a generic version of this product, following CSPC and Hengrui Medicine. Additionally, the marketing applications for albumin-bound paclitaxel submitted by companies such as Hisun Pharmaceutical, Kelun Pharmaceutical, and Kanghe Biopharma are currently under review.

In terms of the median bid price, Celgene, CSPC, and Hengrui were priced at CNY 5,510, CNY 2,680, and CNY 3,280 per 100 mg, respectively. Notably, Celgene has implemented multiple price reductions, with its latest bid price in provinces such as Jiangsu and Shandong standing at CNY 3,350 per 100 mg.

Source: PharmaCube PharmaGo Bid Winning Database

II. Tadalafil Tablets

Tadalafil is a selective, reversible phosphodiesterase-5 (PDE5) inhibitor, originally developed by Eli Lilly. Unlike sildenafil and vardenafil in the treatment of male erectile dysfunction (ED), tadalafil offers a duration of efficacy up to 36 hours, significantly longer than the 3–4 hours provided by the latter two agents, thereby reducing patient concerns regarding dosing timing. In addition, tadalafil is approved for the treatment of benign prostatic hyperplasia (BPH) and pulmonary arterial hypertension (PAH).

Based on the long-acting PDE5 inhibitor, Eli Lilly launched a once-daily, low-dose (5 mg) oral tadalafil in June 2007, revolutionizing the treatment paradigm for male erectile dysfunction (ED). This innovation completely liberated patients from the constraints of dosing timing, enabling tadalafil to gradually catch up with and surpass the market share of the renowned Viagra (sildenafil) in the ED drug market.

Tadalafil, the originator drug, was launched in China in November 2004. The low-dose 5 mg formulation for once-daily use was subsequently introduced in December 2013. The drug is currently no longer under patent protection in China. Qilu Pharmaceutical is the third domestic company to obtain marketing approval for this generic product, following Changchun Haiyue and Nanjing Chia Tai Tianqing.

According to the PharmaGo database of Medicine Magic, in addition to the three manufacturers that have already been approved for market launch, there are 13 companies, including Hengrui and Dongyangguang Pharmaceutical, that have submitted applications under the new Class 4 category. In addition, five other companies are developing oral suspensions and orally disintegrating films.