Summary of Key Points
China’s first gene therapy for Hemophilia B, “Xinjiuniing” (Bopipadocog Injection), was once known as the “most expensive drug” due to a price of 2.79 million yuan per injection. In June this year, although the price was reduced to 1.39 million yuan, it still struggled to find buyers. The company is attempting to apply for inclusion in the 2026 commercial insurance innovation drug list, hoping to address the financial challenges faced by patients through insurance coverage. However, it faces multiple obstacles, including its high cost, lack of long-term efficacy evidence, and the complexity of implementing insurance policies.
I. What exactly is this “expensive drug,” and why is it so costly?
Xinjiuniing is a gene therapy for moderate to severe Hemophilia B. Patients with Hemophilia B are born without enough clotting factor IX, leading to recurrent spontaneous bleeding in joints and muscles, which can be more painful than childbirth and may result in disability (they are often referred to as “glass people”). Traditional treatments require frequent injections of clotting factors throughout life. Xinjiuniing, on the other hand, involves a single intravenous injection that uses a modified virus to deliver the normal clotting factor IX gene directly into the patient’s liver, allowing the body to produce clotting factors on its own—essentially “equipping the body with a ‘clotting factor factory.’”
The technical challenges for developing this drug are immense: modifying the viral vector, ensuring precise gene delivery without side effects, and covering the high research and development costs. As a result, the initial price was set at 2.79 million yuan. It became China’s first approved gene therapy for Hemophilia B in April 2025.
II. Even with a 50% price reduction, it still won’t sell well… Patients simply can’t afford it
Even after the price was cut in half to 1.39 million yuan, patients still have to pay approximately 1 million yuan out of pocket (after considering any government subsidies). Many patient families struggle financially:
- 80% of patient families have an annual income of less than 80,000 yuan;
- The acceptable out-of-pocket range for patients is between 160,000 and 400,000 yuan, with the median willingness to pay being around 50,000 to 80,000 yuan (families with minor children may have a slightly higher ability to pay);
- Doctors report that some patients who hear about the price reduction still shake their heads in despair—many are already impoverished due to the disease and cannot afford such a high cost.
Price remains the main barrier; even with the half-price reduction, it is still far beyond what most patients can afford.
III. Why is it so important to get included in the commercial insurance directory?
Government medical insurance doesn’t cover this drug because of the high one-time cost (1.39 million yuan). If a large number of patients use it, the insurance fund could be depleted. Additionally, medical insurance systems lack mechanisms for installment payments or refunds if the treatment is ineffective, making insurers wary of taking on this risk.
Inclusion in the commercial insurance directory would make it easier for insurance companies to offer coverage (such as through programs like “Huiminbao”). However, being listed doesn’t guarantee automatic approval; companies must negotiate with each city individually and offer discounts. The previous attempt to get included in the 2025 list was unsuccessful, indicating the difficulty involved.
IV. Efficacy is only partially proven, and payment mechanisms are lacking—insurers are hesitant
Insurers have several concerns:
1. Efficacy uncertainty: Doctors say the therapy shows good results in the short term (at least five years), but there is insufficient evidence to prove whether it can provide a permanent cure over the long term (e.g., 10 or 20 years). Insurers fear investing millions only for patients to need further treatment later on.
2. Lack of payment mechanisms: There are no established rules for installment payments (e.g., over five years) or refunds if the therapy is ineffective, leaving insurers responsible for the full cost upfront.
3. Patient mobility: If a patient moves to another city, who would be responsible for covering their insurance costs? These issues have not been clarified.
V. Breaking the commercialization deadlock: Price reduction is just the beginning; we need to solve the “how to pay” problem
For pharmaceutical companies, simply lowering prices is not enough; they must work with insurers to develop flexible payment plans:
- Performance-based payment: Patients could pay the full amount after five years if the therapy is effective; otherwise, a refund would be given.
- Installment payments: Splitting the 1-million-yuan cost over five years (200,000 yuan per year) would reduce the burden on both patients and insurers.
- Promoting inclusion in more government-funded insurance programs to further reduce patients’ out-of-pocket costs.
However, these solutions require collaboration among pharmaceutical companies, insurers, and governments, and cannot be achieved quickly. The challenges faced by Xinjiuniing reflect the broader issue of high-priced innovative drugs: while technological breakthroughs are important, making them accessible to patients remains the real challenge.