Hipsago Makes Progress Toward Commercialization in the U.S., Japan, and China… Kicks Off Global Sales ExpansionAccording to the pharmaceutical and biotech industry on the 22nd, the U.S. Food and Drug Administration (FDA) approved HipSago on the 20th (local time) as a treatment for chronic hepatitis B when used in combination with existing antiviral drugs. HipSago is an antisense oligonucleotide (ASO) drug that received approval in Japan last August as the world’s first product containing the active ingredient bepirivirsen.
Oligonucleotide drugs are medications composed of short, synthesized nucleic acids that target specific genetic information to regulate protein production. Befirovirsen targets the ribonucleic acid (RNA) of the hepatitis B virus to reduce viral protein production. GSK acquired the compound from U.S.-based Ionis Pharmaceuticals and co-developed it.
While existing treatments have focused on suppressing the virus through long-term antiviral therapy, Hepsago aims for “functional cure”—where the virus remains suppressed even after discontinuing the medication following a specific treatment period.
In the U.S., the drug is intended for adults without cirrhosis who have achieved viral suppression after at least six months of treatment with existing antiviral drugs and whose hepatitis B surface antigen (HBsAg) levels are 3,000 IU/mL or lower. In a pooled analysis of Phase 3 clinical trials, 233 of the 1,220 patients in the Hipsago treatment group (approximately 19%) met the criteria for functional cure—no detectable viral DNA or surface antigen for at least 24 weeks after discontinuing all treatment.
In Japan, sales began following approval in August. According to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), Hipsago was listed on the national health insurance drug price list on the 14th of this month, and sales began on the same day.
Its sales potential is also drawing attention. According to the earnings consensus of 15 global financial institutions, including JPMorgan, released by GSK this month, Hipsago’s sales are projected to increase from 123 million pounds (approximately 218 billion won) next year to 967 million pounds (approximately 1.7137 trillion won) in 2031. It is projected to grow into a blockbuster drug with annual sales exceeding 1 trillion won.
The approval process is also underway in China. In April of this year, the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) included HipSago in its priority review program. Sinobiopharm, the local commercialization partner, expects GSK to receive a regulatory decision from the NMPA in the first half of next year. CTTQ, a subsidiary of Sinobiopharm, is set to handle importation, distribution, and hospital access locally once marketing authorization is granted.
EST Pharm Co., Ltd.’s Commercial Focus Grows… Considering Expansion to Meet Additional DemandAmid a series of positive developments regarding Hipsago, attention in South Korea is focusing on the potential benefits for ST Pharm Co., Ltd. Although neither GSK Holdings nor ST Pharm Co., Ltd. has officially confirmed this, the biotech industry and securities analysts have long assumed that ST Pharm Co., Ltd. is the sole supplier of the active pharmaceutical ingredient (API) for befirovirsen.
Previously, in February 2023, ST Pharm Co., Ltd. announced that it had secured an order for active pharmaceutical ingredients (APIs) for a Phase 3 clinical trial of an oligonucleotide treatment for chronic hepatitis B from a global pharmaceutical company based in Europe. The contract was valued at $7.77 million, equivalent to approximately 9.8 billion won at the exchange rate at the time. In financial results released in February of the following year, the company reported annual sales of 10.6 billion won from oligonucleotides related to chronic hepatitis B for “Company G.”
Active pharmaceutical ingredient (API) suppliers have the opportunity to expand their business into commercial API production once the new drug they were supplying for clinical trials receives approval. This is because moving from the stage of producing APIs for clinical trial participants to the stage of supplying them to patients with actual prescriptions can lead to increased production volumes and opportunities for repeat orders.
Yoon Seok-hyun, an analyst at Shinhan Investment Securities, noted, “In contract manufacturing (CMO), orders for commercial volumes are linked to the sales volume of approved drugs, resulting in high repeatability,” adding, “Since these orders are significantly larger than clinical volumes, they have a positive impact on both revenue and profit.”
ST Pharm Co., Ltd. is already shifting its focus from clinical-use production to commercial supply. An ST Pharm Co., Ltd. official stated, “In the past, clinical volumes accounted for the majority, but now about 65% of our oligonucleotide sales come from commercial volumes,” adding, “We are definitely entering a more stable phase.”
The spokesperson added, “We expect the company’s revenue to rise as more oligonucleotide-based new drugs from global pharmaceutical companies are commercialized.”
The company is also considering expanding its production facilities. ST Pharm Co., Ltd. completed construction of the Second Oligo Building at its Banwol Campus last September and began full-scale production in the fourth quarter of the same year. The 6th and 7th floors of the building have been reserved as expansion space to accommodate future demand.
A ST Pharm Co., Ltd. official said, “The 6th and 7th floors of the Second Oligo Building have been reserved for future expansion,” adding, “Although nothing has been finalized yet, we are reviewing the possibility of additional expansion on those floors.” The company anticipates future demand growth and explained that it will need to review whether to proceed with additional expansion around the end of the year.
However, the company expressed caution regarding the possibility of rapid growth in the short term. A representative of ST Pharm Co., Ltd. said, “Since there aren’t many new RNA and oligonucleotide drugs yet, the market itself isn’t very large,” adding, “Explosive growth remains unlikely at this point.”
