Boryung (formerly Boryung Pharmaceutical), a strong player in the domestic anticancer drug market, draws the industry’s attention by tying up with Bixink Therapeutics, which holds the domestic rights to Nerlynx Tablets (neratinib maleate), a new drug for HER2-positive breast cancer.

Bixink Therapeutics said Thursday that it has signed a co-promotion agreement with Boryung for breast cancer treatment. Accordingly, starting this month, Bixink Therapeutics and Boryung will begin jointly selling and marketing each other's breast cancer drugs, Nerlynx and Fulvet (fulvestrant).

Nerlynx is an oral HER2-positive breast cancer treatment developed by Puma Biotechnology of the United States. It was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant therapy indication and later added the indication for treating metastatic HER2-positive breast cancer.

Nerlynx is recommended by the U.S. National Comprehensive Cancer Network (NCCN) guidelines for treating early-stage and metastatic breast cancer and has demonstrated efficacy in reducing the risk of recurrence in HER2-positive early-stage breast cancer in a phase 3 clinical trial. ExteNET.

While existing drugs, including Herceptin (trastuzumab), Perjeta (pertuzumab) combination therapy, and Kadcyla (trastuzumab emtansine) have demonstrated the effectiveness of reducing the recurrence rate of HER2-positive breast cancer patients through clinical studies, Nerlynx has attracted attention for its effectiveness in preventing brain metastasis.

In October 2021, Bixink Therapeutics, which introduced Nerlynx in Korea, obtained domestic approval from the Ministry of Food and Drug Safety. The domestic license indication is extended adjuvant treatment of early breast cancer. With the latest co-promotion agreement, Bixink Therapeutics expects the number of Nerlynx prescriptions in Korea to increase.

However, the drug’s high cost remains a hurdle to surmount for Bixink and Boryung. The supply price of Nerlynx for a month's supply (180 tablets) is 7 million won ($5,195). Bixink Therapeutics has applied for health insurance benefits but has failed to get them. In the first year of its launch, Nerlynx reportedly generated 6 billion won in annual sales.

In addition, prescription competition became inevitable as MSD Korea won domestic approval for its HER2-positive breast cancer drug Tukysa (tucatinib hemiethanolate) last December. Tukysa is also gaining attention for its effectiveness in preventing brain metastasis in HER2-positive metastatic breast cancer patients.

"In addition to collaborating with Boryung equipped with the ‘anticancer drug growth engine,' we have begun to launch Mucosamin to prevent and treat canker sores in cancer patients, with Shin Poong Pharm this year," Bixink Therapeutics CEO Han Mi-kyung said. "We will strive to achieve annual sales of 10 billion won by accelerating our vision of anticancer treatment ONE-STOP-SERVICE.’”