pharm edaily

[Seok Ji-hoen, Edaily Reporter] Biosolution, a South Korean cell therapy company, is accelerating its push into the Chinese market. The company is in discussions with the Hainan Medical Products Administration and major hospitals, aiming to enter the market within the first half of this year.

Jeong-seon Lee, Biosolution CEO.

According to an Edaily report on March 30, Biosolution is in advanced negotiations with the Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration and leading Chinese hospitals to directly launch CartiLife, its autologous cartilage cell therapy for knee osteoarthritis. Talks with the hospitals reportedly include efforts to be listed on Hainan’s “whitelist.”

Products included on this whitelist can be sold to patients in the Hainan zone without formal approval from China’s National Medical Products Administration (NMPA), under a special exemption. Inclusion can also positively influence future NMPA reviews, as the whitelist is considered a form of national-level endorsement.

In November 2023, Biosolution signed a four-party memorandum of understanding (MOU) with Boao Lecheng Development Co., Northland Biotech, and Aiker Pharma to enter the Hainan medical pilot zone. China is currently running a “medical openness pilot project” in key cities like Beijing, Shanghai, Guangzhou, and Hainan, allowing overseas cell and gene therapies to be manufactured, prescribed, and administered in those regions even without NMPA approval.

Biosolution has emerged as one of the most proactive participants in the Hainan pilot project. In the region, companies can sell and distribute products without full clinical trials or with only simple bridging studies if they obtain approval from local Hainan authorities rather than the NMPA. Since 2013, Hainan has been designated a special medical zone, with national medical institutions and facilities compliant with GMP standards concentrated in the area, enabling rapid market entry for newcomers.

Some drugs produced in the zone can also be distributed to other parts of China. Keraheal-Allo, another Biosolution product, has a shelf life of over six months, allowing it to be shipped to hospitals in regions with demand.

The company had not disclosed significant progress since the MOU was signed in November. However, the recent updates suggest that CartiLife sales and related revenue could begin as early as the first half of this year.

CartiLife is Biosolution’s flagship product, a fourth-generation autologous cartilage cell therapy using healthy costal cartilage tissue instead of damaged knee cartilage. The company recently received the final clinical study report (CSR) for a Phase 3 trial conducted over 96 weeks. Biosolution plans to submit a formal product license application to the Korean Ministry of Food and Drug Safety (MFDS) in the first half of 2025.

According to the international journal Arthritis & Rheumatology, China had more than 130 million patients with cartilage damage or osteoarthritis as of 2019?the largest such population in the world. That’s more than triple the estimated 40 million in the U.S. and 30 times more than South Korea’s 4.37 million.

At a recent shareholder meeting, CEO Jeong-seon Lee said, “China’s medical community has shown great interest in autologous cartilage therapies like CartiLife, and we are optimistic about the opportunity.”

In addition to CartiLife, Biosolution plans to submit an investigational new drug (IND) application in the U.S. within the first half of the year for Cartiloid, an allogeneic cartilage cell therapy. The company is also preparing IND applications for Phase 1/2 trials of CartiCureCell, which is being developed as a disease-modifying osteoarthritis drug (DMOAD).