As of the Latest Practicable Date, our Core Products had not been included in the NRDL.
Business · 第 184 页
We currently expect to submit an NRDL application after product approval and participate in the annual NRDL price negotiation subject to regulatory approval and the progress of commercialization.
Business · 第 184 页
Based on historical NRDL negotiation practice, successful inclusion in the NRDL may require significant price concessions, and the negotiated price would generally form a unified national medical insurance payment standard.
During the Track Record Period, the prices of icotinib, ensartinib, befotertinib and vorolanib remained stable after the price reduction via pricing negotiation process for NRDL inclusion, and was not materially affected by pricing pressure from manufacturers of competing products.
Business · 第 171 页
During the Track Record Period and up to the Latest Practicable Date, our products were not sold through the centralized VBP system.
Business · 第 171 页
On balance, the benefits of inclusion of our pharmaceuticals in the national or provincial medical insurance programs in China significantly outweighed the costs of such inclusion during the Track Record Period, and we believe the benefits of such inclusion will continue to contribute to our business expansion in the foreseeable future.
Both ZEGFROVY^®^ and golidocitinib were included in the NRDL in 2024, which took effect on January 1, 2025.
Financial Information · 第 240 页
The regulatory regimes that directly impact golidocitinib’s pricing and market access primarily include the NRDL governing insurance coverage and reimbursement standards.
Business · 第 186 页
We continuously monitor regulatory developments and adapt our pricing strategy to navigate these complex mechanisms while maintaining sustainable business operations.
征祥医药(南京)集团股份有限公司Zenshine Pharmaceuticals (Nanjing) Group Co., Ltd.
NRDL准入及省级集中招标定价影响
We have submitted the application material for the inclusion of our Core Product in the NRDL to the NHSA in June 2026, which is currently under review.
Summary · 第 19 页
While NRDL inclusion typically necessitates negotiated price reductions, it significantly expands market access by reducing out-of-pocket costs for patients.
Business · 第 184 页
As of June 30, 2026, we had completed the online price filing process for our Core Product in all 31 provinces in China.
Following the inclusion in the NRDL, our pricing was adjusted to align with the medical insurance reimbursement standards and subject to a two-year dynamic adjustment mechanism.
Business · 第 175 页
While NRDL inclusion generally involves a reduction in drug prices, we expect the resulting increase in sales volume to substantially offset the impact of such price reductions and continue to support the sustainable growth of our revenue and profitability.
Business · 第 175 页
Following its inclusion in the NRDL in January 2022, the retail price was reduced from RMB8,266 to RMB2,592 per box, while its sales volume increased significantly from approximately 28.6 thousand boxes in the second half of 2021 (following its launch in June 2021) to approximately 173.4 thousand boxes in 2022.
However, this may also lead to a decrease in the price of our products in certain provinces due to the transparent, multi-party negotiation mechanism for pricing.
Business · 第 165 页
NRDL inclusion enhanced its affordability, drove market adoption, and led to a significant increase in its sales volume, which effectively offset the impact of the price reduction.
Business · 第 188 页
Overall, we believe that during the Track Record Period, the overall benefits of our drugs being included in the NRDL, provincial, or local medical insurance catalogs far outweighed the associated pricing pressure, and we believe these benefits will continue to contribute to our business growth in the foreseeable future.
Furthermore, to broaden patient access, we consider that the initial annual treatment cost may be set at no more than one-half of the price of ustekinumab (i.e. from RMB52,735 to RMB119,850).
Business · 第 171 页
We plan to participate in the 2026 NRDL price negotiation, targeting reimbursement implementation in 2027.
Business · 第 172 页
Should NRDL inclusion not be achieved as planned, we will adjust our pricing and commercialization approach to ensure patient access and market uptake during the self-pay period, while continuing to advance market education and support initiatives.
The price of azvudine was lowered from RMB270 per box to RMB174.65 per box after the inclusion to the NRDL.
Business · 第 200 页
During the 2024 NRDL negotiations, leveraging its superior product quality and proactive market strategies, azvudine successfully remained included in the NRDL with the coverage and price paid for our products unchanged.
Business · 第 200 页
Therefore, before the emergence of generic versions of azvudine in China market, the medical insurance reimbursement price of azvudine will remain very stable.
Our pricing strategies are affected by the regulatory framework governing pharmaceutical reimbursement in China, which operates through multiple interconnected mechanisms that collectively determine both market access opportunities and pricing parameters for pharmaceutical products in China’s public healthcare system.
Business · 第 182 页
As of the Latest Practicable Date, we have been making steady progress in advancing the inclusion of our Core Product in the NRDL.
Business · 第 182 页
However, we cannot guarantee that it will be included, as the final determination is subject to complex pricing negotiations and government policies that are ultimately beyond our control.
The retail price for senaparib after NRDL inclusion is consistent nationally, and at RMB4,650 per box.
Business · 第 219 页
Such reimbursement rates are on average around 70% of the retail price for innovative drugs like senaparib included in the NRDL, and is consistent with the industry norm, according to Frost & Sullivan.
Business · 第 219 页
Following NRDL inclusion in December 2025, senaparib has been reimbursable for 1L maintenance therapy for OC “all-comers” since January 1, 2026, which we believe will significantly broaden patient access and accelerate uptake across all regions, especially key clinical regions.
Taking these factors into account, we set the list price of Junmaikang at RMB998.0 per unit, Mailishu RMB613.80 per unit and Maiweijian RMB1,043.46 per unit.
Business · 第 218 页
Being part of the NRDL has substantial implications as it determines the medical insurance reimbursement standards for our products.
As of December 31, 2025, eight of our approved products were included in the NRDL, comprising three key marketed products, Kangmairui, Li’erban and Dinuo’an, and five other products, namely azacitidine, silodosin, temozolomide, esomeprazole sodium and sugammadex sodium.
Financial Information · 第 217 页
Our revenue from sales of our these products accounted for 20.4%, 31.6% and 29.3% of our total revenue, respectively, for the years ended December 31, 2023, 2024 and 2025.
Financial Information · 第 217 页
While the inclusion of a pharmaceutical product in these national or other government-sponsored medical insurance programs can significantly increase its demand and potentially sales volume, products so included were subject to relevant pricing regulation and face pricing pressure in the centralized tender process.
Our commercialized product Sangbo'en has been included in the NRDL since 2020, and its pricing aligns with the medical insurance reimbursement standards and is subject to dynamic adjustment mechanism.
Business · 第 191 页
We will determine the prices of our products based on a number of factors, including our costs of production, technology advantages, differences in features between our drugs and competing drugs, affordability of patients and changes in the levels of supply and demand.
For the products which are included or planned to include in the NRDL, such as rebamipide, our pricing will align with the medical insurance reimbursement standards and be subject to dynamic adjustment mechanism.
Business · 第 375 页
In Uzbekistan, our pricing may not exceed a specified allowable markup on the ex-factory price in accordance with relevant regulations.
By the end of 2023, we commercialized KBP-3571, which was approved in June 2023 and subsequently included in the 2024 NRDL in December 2023 with a negotiated price of RMB11/20mg.
Business · 第 345 页
While the end-market price of KBP-3571 was set by the price guidance after its inclusion in NRDL (ceiling price: RMB11/20mg), we sell KBP-3571 to our distributors at a mutually agreed upon price with a profit margin offered as an industry norm.
Business · 第 346 页
In light of this, we expect the end-market price of XZP-3287, which is anticipated to launch in 2025, to also be set by the price guidance as we will strive for its inclusion in the NRDL.
脑动极光医疗科技有限公司BrainAurora Medical Technology Limited06681.HK
院内定价参考省级医保报销目录
The pricing is set based on negotiations between us and the hospitals with reference to the relevant provincial health insurance reimbursement list.
Business · 第 329 页
As of the Latest Practicable Date, the price for cognitive training in hospitals ranges from approximately RMB10.0 to RMB930.0 per session, depending on the content and number of training sessions actually received by the patient.
Business · 第 338 页
However, we may face downward pricing pressure if our products are included in the government insurance coverage, even if such inclusions are expected to increase the sales volume of our products.
In January 2023, Utidelone Injection was officially included in the 2022 NRDL and has been sold at an agreed price that was negotiated with the government since March 1, 2023, which alleviated financial burden on patients and expanded our market reach.
Summary · 第 16 页
If the ratio is between 110% and 200%, the reduction in NRDL prices will not exceed 15%.
Business · 第 365 页
In particular, based on our current estimation with reference to our sales, it is expected that the actual expenditure will be lower than budget expenditure and the ratio will be less than 110%, which could enable a drug negotiation agreement for the Utidelone Injection to be renewed without price reductions until the end of 2026 according to the Renewal Rules.
As of the Latest Practicable Date, there was no pricing guidance or centralized procurement requirement set by the PRC government on our drug candidates.
Business · 第 366 页
In terms of pricing strategies for TY-9591, we plan to set a price with reference to, and not lower than, the price of osimertinib (namely, RMB4,966.2 per month).
Business · 第 366 页
However, inclusion into the NRDL is evaluated and determined by the relevant government authorities and we may face significant competition for successful inclusion.
We will face pricing pressure for our BsAb drug candidates due to fierce competition in the market.
Summary · 第 21 页
However, for a pharmaceutical product to be included on the NRDL, a ceiling of such product’s reimbursable amount under the national medical insurance will be determined based on negotiation with the government.
Summary · 第 21 页
To navigate through such pricing pressure and competition, we (i) develop our Core Product, M701, with differentiated market positioning for the treatment of MA and MPE, (ii) develop stable, high-yield processes under our technology platforms, including YBODY^®^, Check-BODY and Nano-YBODY^™^, to produce high-purity BsAb, (iii) maintain clinical dosages of our drug candidates at the microgram or milligram level with our high-yield CMC process, ensuring that each treatment course requires minimal medication quantities, thus lowering costs of treatment of our drug candidates and balancing patient affordability with our profitability, and (iv) seek strategic collaborations and contract part of our manufacturing process to CMOs/CDMOs to reduce upfront investment costs.