Kexing Biopharm introduces Humanwell PuraCap's Nintedanib Ethanesulfonate to kickstart its global journey in respiratory field

Recently, Kexing Biopharm (688136.SH) announced a collaboration with a well-known pharmaceutical company in the industry, Humanwell's wholly-owned subsidiary, Humanwell PuraCap (Wuhan) Co., Ltd. (hereinafter referred to as PuraCap), has reached an overseas commercialization partnership for Nintedanib Ethanesulfonate Soft Capsules. This collaboration adds a respiratory product to the portfolio of Kexing Biopharm, further highlighting the company's robust capabilities in overseas commercialization.

Major Respiratory Drug Sees Global Commercial Value Continue to Rise

Nintedanib Ethanesulfonate Soft Capsules are one of only two globally approved and guideline-recommended treatments for idiopathic pulmonary fibrosis (IPF), with the other being pirfenidone. The main indications are idiopathic pulmonary fibrosis (IPF), chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype, and slowing the rate of lung function decline in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).

As a multi-target tyrosine kinase inhibitor, nintedanib slows the process of pulmonary fibrosis by inhibiting fibroblast proliferation and inflammatory responses through blocking the activity of vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor (PDGFR), and fibroblast growth factor receptor (FGFR). With proven clinical efficacy and safety, the original drug has become a core choice for clinical treatment in the respiratory field in dozens of countries and regions worldwide, including China, the United States, and the European Union. Humanwell PuraCap's Nintedanib Ethanesulfonate Soft Capsules is a dual filing project in China and the U.S., was approved domestically in 2023, and is expected to be approved in the U.S. by 2026.

In terms of commercial value, Nintedanib Ethanesulfonate demonstrates strong growth momentum. According to Boehringer Ingelheim original research annual report, sales reached 3.51 billion euros in 2023 and increased to 3.766 billion euros in 2024, representing a year-on-year growth of 7.3%. Meanwhile, data indicates that the number of global Idiopathic Pulmonary Fibrosis (IPF) patients grew from 1.4 million in 2015 to 1.7 million in 2022, with a compound annual growth rate (CAGR) of 3.0%. It is projected that the number of patients will reach 1.8 million by 2025. As a key anti-fibrotic product in the respiratory field, Nintedanib will continue to maintain robust growth.

Targeting Global Expansion, EU Market Holds Huge Potential

The overseas commercialization cooperation regions for Nintedanib Ethanesulfonate this time include all other countries and regions worldwide, except for China (including Hong Kong, Macao, and Taiwan), the United States, Saudi Arabia, Ecuador, Bolivia, Paraguay, and Uruguay.

As a pioneer in the internationalization of Chinese pharmaceutical enterprises, Kexing Biopharm has, through over three decades of profound accumulation in the biopharmaceutical field, developed a comprehensive international capability covering overseas market insights, efficient registration applications, and precise marketing promotions. This has also made "rapid registration" a core competitive advantage in the company's international endeavors. The internationalization of its core product, albumin-bound paclitaxel, can be regarded as a benchmark: since its approval by the EU in 2024, albumin-bound paclitaxel has successfully entered more than 30 countries and regions worldwide, becoming one of the flagship products in its overseas commercialization portfolio.

The smooth progress of albumin-bound paclitaxel in the EU has also advanced Kexing Biopharm's overseas commercialization to the 2.0 era, achieving expansion from emerging markets to the EU market. Its overseas marketing channels now cover up to 70 countries and regions. With a platform-based outbound model of "global product selection, global coverage," the company establishes subsidiaries or offices in key overseas markets to strengthen localized marketing and further cultivate pharmaceutical markets in the EU, Latin America, Southeast Asia, and the Middle East and North Africa.

The rapid launch of albumin-bound paclitaxel in Europe has validated the overseas registration efficiency, localized team execution, and channel coverage capabilities of Kexing Biopharm. Notably, the overseas commercialization of Nintedanib Ethanesulfonate also includes EU market rights, further expanding Kexing Biopharm' product portfolio in the EU market.

Humanwell's PuraCap was founded in 1993 and listed on the Shanghai Stock Exchange in 1997. It is a leading pharmaceutical company in Hubei Province, ranked among China’s top 20 pharmaceutical enterprises, and recognized as a National Enterprise Technology Center, a National Technology Innovation Demonstration Enterprise, and a pioneer in the internationalization of Chinese pharmaceutical formulations. The company has established leading positions in multiple niche areas, including neurological drugs, steroid hormones, and traditional Uyghur medicines.

As a wholly-owned subsidiary of Humanwell Healthcare, PuraCap’s strong R&D and manufacturing capabilities are expected to synergize with Kexing Biopharm’s overseas commercialization expertise. Combined with the global clinical recognition of Nintedanib Ethanesulfonate and the advantage of dual submissions in China and the U.S., this collaboration holds significant promise.