Recently, Tebo Bio's independently developed Yipei Growth Hormone Injection (trade name: Yipeisheng) 10mg specification was officially approved for marketing by the National Medical Products Administration. This is another expansion of Yipeisheng's product portfolio, following the availability of four specifications: 2.5mg, 3.0mg, 3.5mg, and 5.0mg.
On the surface, this might seem like just a routine specification update. But for long-acting growth hormone, going from 5mg to 10mg is not simply adding another line to the instructions.
In recent years, with the approval of several long-acting growth hormones, "once-a-week" dosing is no longer a label exclusive to any one company. As "long-acting" gradually becomes the industry standard, the focus of competition is quietly shifting downwards—clinical evidence, dosage accuracy, specification compatibility, and the underlying formulation technology barriers. The approval of the 10mg specification has brought this change to the forefront.
From 5mg to 10mg
To understand the value of 10mg, we need to go back to the clinical use scenario.
Short-acting growth hormone typically requires daily injections, while long-acting products, through technological improvements, reduce the dosing frequency to once a week, significantly decreasing the number of injections required for long-term treatment. However, an easily overlooked issue is that weekly dosing does not mean that only one injection is needed each time.
Growth hormone treatment is a long-term process, and the dosage needs to be individually adjusted based on the child's weight, indications, and treatment response. As the child's weight increases, the amount of medication required for a single administration also increases accordingly. Some large-weight children with high-dose requirements who use long-acting formulations may need multiple injections at once, which diminishes the "convenience" of long-acting growth hormone in clinical practice.
The approval of the 10mg dosage is precisely to cover this medication scenario. Together with the four previously approved dosages, Yipesen now has a complete dosage range from 2.5mg to 10mg, giving doctors more flexibility in choosing the appropriate dosage based on the child's condition; for families, it may also reduce the extra handling required for multiple doses and improve the convenience of long-term administration.
Large-scale hidden door sill
However, for a protein drug, "adding a larger dose" is far from as easy as it sounds.
Unlike small-molecule drugs with relatively simple structures, growth hormones are protein drugs, and their biological activity is highly dependent on their specific molecular spatial structure. Proteins are sensitive to temperature, pH, concentration, and formulation environment; changes in any of these factors can affect the quality of the final product. Especially when large-scale development means increasing protein concentration, the enhanced intermolecular interactions may increase the risk of protein aggregation and degradation, thereby affecting the drug's activity, stability, and even potential immunogenicity.
This means that researchers cannot simply double the protein content in the original formulation; they need to reassess whether the formulation system can remain stable and whether the manufacturing process can consistently guarantee product quality. Once in the industrialization stage, further issues regarding quality consistency, batch stability, and process controllability must be addressed.
In other words, large-scale development tests not just a single technology, but a systemic capability encompassing molecular design, formulation development, manufacturing processes, and quality control. This is precisely why the approval of the 10mg specification deserves to be discussed separately.
Tebo Bio's success in reaching this stage is directly related to its accumulated core technologies. Yipeisheng uses 40kD Y-branched polyethylene glycol (YPEG) to modify human growth hormone into a single molecule, extending its half-life to 65-120 hours, enabling once-weekly dosing. Its Phase III clinical trial employed a head-to-head design with imported short-acting growth hormone. After 52 weeks of treatment, the annualized growth rate in the Yipeisheng group was 9.910 cm/year, comparable to the 10.037 cm/year of the imported daily formulation, achieving non-inferiority. The detection rates of newly added anti-drug antibodies and newly added neutralizing antibodies were both 0.0%, while the corresponding rates in the control short-acting group were 26.4% and 7.9%, respectively.
At the formulation and administration device level , Yipeisheng adopts a preservative-free design and is equipped with a "single-use + hidden needle" integrated drug compartment, which reduces manual drug extraction and avoids dosage errors that may be caused by piecing together the drug solution; its matching Yushida smart injection pen has a hidden needle throughout the injection process, which can automatically identify the drug specifications and dosage, control the injection speed, and synchronize the data to the mobile phone to assist parents and doctors in long-term medication management.
The "battle of the titans" for long-acting growth hormone.
The significance of the approval of the 10mg specification becomes clearer when viewed within the context of the entire industry.
Currently, there are four main long-acting growth hormones approved in China : Jinsai Pharmaceutical's "Jinsai Zeng" (approved in 2014), Tebo Bio's "Yipeisheng" (approved in May 2025), Novo Nordisk's "Nuozeyou" (approved in December 2025), and Weisheng Pharmaceutical's "Weizhengao" (approved in January 2026). Among them, Jinsai Zeng and Yiipeisheng have been included in the 2025 National Medical Insurance Catalog, and will be covered by medical insurance starting in January 2026. The reduction in medical insurance prices is accelerating the replacement of short-acting products with long-acting ones, shifting competition in the market from "first-mover advantage" to "internal strength competition."
As more and more products feature once-weekly dosing, competition is no longer limited to the dosing cycle. The sufficiency of clinical evidence, the precision of dosage adjustments, the suitability of dosage for different children, the convenience of the injection device, and drug accessibility all affect a product's actual competitiveness. Yipeisheng's multi-specification strategy is precisely adding leverage to its competitiveness at this stage.
Judging from Yipesen's own pace, it was approved for marketing in May 2025, included in medical insurance in December 2025, its broader safe dosage was included in international consensus in August 2026, and the 10mg specification was approved in October 2026. In addition to the approved indication for growth hormone deficiency (GHD), indications such as idiopathic short stature (ISS), small for gestational age (SGA), and Turner syndrome (TS) are all in the clinical research stage.
These strategic moves are translating into commercial value. Tebo Bio's Q3 2026 report shows that Yipeisheng sales increased by 264.27% year-on-year in Q3 2026 , establishing a second growth curve.
Conclusion
Returning to the approval of the 10mg specification, it is not only a refinement of Yipeisheng's product portfolio, but also a microcosm of the deepening competition in long-acting growth hormone towards personalized dosage adaptation and user experience.
As the market enters a phase of multi-product competition, what truly determines how far a company can go may not be just whether it can launch an innovative drug, but rather whether it can continuously transform its technological accumulation into products with clinical value that meet the actual needs of patients. The competition in long-acting growth hormone has only just begun to move from the question of "whether it exists" to the question of "how well it works."

Source: https://news.yaozh.com/archive/49290.html