China has approved another bromhexine hydrochloride oral solution, a dosage form the report describes as closing a paediatric gap for a top-selling cough and cold ingredient. For families coming to Shanghai, formulation is a practical question: it affects what a prescription can actually be filled with, how much medicine a family must carry, and what to ask at the appointment. Two device approvals reported in the same window are also better read as measurement-based criteria — age, weight, artery size — than as a general statement that an intervention is available; hospital-level availability still needs confirmation.
What was approved, in the report’s own numbers
A bromhexine hydrochloride oral solution has been approved for market launch in China, according to a report published by Menet (menet.com.cn) on 30 October 2026. The report attributes the approval to Hunan Pudao Pharmaceutical, a subsidiary of Hunan Jiudian Pharmaceutical, and lists bromhexine hydrochloride as already marketed in China as tablets, oral solution and granules, describing the oral solution as the form that filled this variety’s gap in children’s use.
The same report places bromhexine among the top seven cough and cold medicine varieties in China, with 2025 sales of 1.04 billion yuan across the country’s three terminal markets and six sub-markets. It records that the first bromhexine hydrochloride oral solution reached the domestic market in 2022, that more than 20 Chinese manufacturers now hold approval for this form, and that public-hospital sales of the oral solution grew 114.34% in 2025 and 26.60% in the first half of 2026. The injectable form, it adds, was included in the eleventh national volume-based procurement round while oral sales kept rising.
Manufacturer-level detail continues: since the start of 2026, Jiudian is reported to have accumulated one Class 1.1 traditional Chinese medicine new drug and 17 generic approvals, with one Class 3.1 product (Qingjin Huatan Tang granules) and 17 generics still under review, and its cough and cold portfolio standing at six products as of 28 October 2026. Those are company figures. They say nothing about whether any specific Shanghai hospital stocks any specific product.
Why a dosage form is a logistics question for a travelling family
For a family arriving with an outside prescription, the difference between a tablet and a liquid is usually practical rather than scientific. The published reports do not describe patient-level situations, but the pattern is one cross-border families recognise: the active ingredient is easy to find, and a child-friendly form is the part that needs asking about. Whether a tablet may be divided, or a suspension prepared, is a decision for the examining paediatrician, not something to improvise between appointments.
Formulation also shapes the trip. It affects how much medicine a family carries on arrival, whether a refill has to fall inside the visit window or after the return home, whether a separate pharmacy stop is needed, and therefore how the medication line of a budget is written. Whether a given bromhexine product in a given form is on a hospital’s list, and whether an imported prescription can be matched to it, has to be confirmed with the hospital; nothing in this approval settles that.
Questions worth adding to the appointment list
- Is an oral solution or granule form of this ingredient used here, or only tablets?
- How will the dose be calculated for this child’s weight, and can we have it in writing?
- If the form changes, what instructions should we take home to our local doctor or pharmacist?
- Which ingredient name should we search for here, since brand names will not match?
- For long-term medicine alongside cardiac or respiratory follow-up, when must a refill be arranged?
- What does this cost per pack, and is any part of it claimable?
Two paediatric device approvals that arrive with fixed criteria
In the same period, the national medical products regulator approved three innovative medical devices, two of them for populations defined as children, according to a report published on cnpharm.com on 28 October 2026. For planning purposes the useful part is that the approved wording reads like a list of measurements rather than a general statement that an intervention exists.
| What was approved (as reported) | Fixed lines inside the approved range | What to verify before you travel |
|---|---|---|
| A transcatheter pulmonary valve system, for severe pulmonary regurgitation after reconstruction of the autologous right ventricular outflow tract in complex congenital heart disease | Age 9 years or older and weight 20 kg or more; main pulmonary artery diameter 16 mm or more and length 20 mm or more; a cardiac surgery and cardiovascular team must judge that valve replacement is needed, that medicine alone has not worked, and that conventional surgery is not tolerated or the next operation must be delayed. The report states the device does not replace open surgery. | Which of our imaging measurements already answer these lines; whether a surgical team assessment exists; whether the target hospital performs this procedure and accepts international referrals for it |
| An auditory brainstem implant system, described in the report as the first of its kind approved in China | Children aged 2 to under 6 years; severe prelingual deafness that is neither tumour-related nor syndrome-related; severe inner-ear malformation (Michel aplasia, common cavity, cochlear aplasia or CH-1 severe hypoplasia) or an absent auditory nerve, so a cochlear implant cannot be placed; used together with the same manufacturer’s speech processor | Whether the inner-ear and auditory-nerve imaging supports the described pattern; whether the hospital performs this implant and can fit and program the matching processor, and who does the follow-up after we fly home |
| A fluorescence in-situ hybridisation assay for chromosome 3 and 10 abnormalities, for people with a lung nodule on chest CT | The report describes it as an adjunct for deciding whether an invasive test is needed when imaging alone is inconclusive; it is not presented as a paediatric test | Outside the scope of this article; ask the relevant department directly if this concerns your child |
What these approvals do not decide
Institution-level news and one child’s pathway are different things. A marketing approval says a product or device exists and may be used inside its approved range; it does not say that a particular Shanghai hospital stocks it, offers it to international patients, or that your child falls within the described population. The reports do not specify hospital availability, price, waiting time or interpreter support, and this article does not infer them — each of those needs confirmation with the hospital.
ChildMedCare is an editorial resource, not a hospital, and does not speak for Shanghai Children’s Medical Centre or any other institution. Clinical judgement about formulation, dose, device candidacy and timing belongs to the licensed paediatric team who examine the child. The checklist below is assembled by our editors as a planning tool; it is not an admission or intake requirement from any hospital.
Assembling the medication side of your records
Build the medication list on ingredient names, current strength, current form and daily schedule, and keep any written note from the treating doctor about dose adjustment, because a local product with the same ingredient may only come in a different form or pack size from the one at home. Photograph labels instead of transcribing brand spellings, and carry enough supply to cover the visit plus the interval before a refill can be arranged. Our medical-records guide and cost-estimate checklist are the companion planning tools for the same trip; price and reimbursement questions go to the hospital’s international patient office and your insurer, since neither October report gives pricing for these products.
Planning checklist
- Match medicines by ingredient and form, not by the home brand.
- Ask whether a solution or granule form exists for each item.
- Request the weight-based dose calculation in writing at the visit.
- Count days of supply for the stay, plus the gap before refill.
- Bring imaging measurements that answer the device criteria.
- Confirm availability, price and interpreter support with the hospital.
Sources & further reading
- 10亿品种新剂型，九典制药成功拿下 ↗
Supports the approval of the bromhexine hydrochloride oral solution, the marketed dosage forms, the category sales and growth figures, the number of holders of the oral-solution approval, the injection’s inclusion in the eleventh procurement round, and Jiudian’s 2026 approval and review pipeline.
- 3款创新医疗器械获批上市 ↗
Supports the three innovative device approvals, the transcatheter pulmonary valve system’s age, weight and anatomy criteria and its non-substitution for open surgery, the auditory brainstem implant’s age and imaging criteria and speech-processor pairing, and the lung-nodule assay’s described use.
Sources checked November 2, 2026. Planning checklists are ChildMedCare editorial guidance; they are not hospital admission requirements.