YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 29 drug applications between 28 January 2025 and 3 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 10, covering 9 drug names.
2025/01/28 – 2025/02/03
- New acceptances this week
- 29
- Drugs with new generic filings (by drug name, de-duplicated)
- 9
- Accepted this week, now under review
- 0
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
29filings, 10 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 12 |
| Generic | 10 |
| New drug | 6 |
| Unspecified | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 21 |
| Therapeutic biologic | 4 |
| TCM | 2 |
| Biologic | 1 |
| Prophylactic biologic | 1 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
9 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Amoxicillin Sodium and Clavulanate Potassium for Injection | 2 | 1 | 4 |
| 2 | 泊沙康唑注射液 · No verified English name | 1 | 1 | 1 |
| 3 | Amiodarone Hydrochloride Injection | 1 | 1 | 0 |
| 4 | 碳酸氢钠/葡萄糖2mmol/L钾电解质血滤置换液 · No verified English name | 1 | 1 | 0 |
| 5 | 磷/碳酸氢钠血滤置换液 · No verified English name | 1 | 1 | 4 |
| 6 | Oseltamivir Phosphate Capsules | 1 | 1 | 39 |
| 7 | Oxytocin Injection | 1 | 1 | 8 |
| 8 | Calcium Acetate Oral Solution | 1 | 1 | 1 |
| 9 | Alendronate Sodium Oral Solution | 1 | 1 | 7 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
22 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Haikou Shi Pharmaceutical Factory Co., Ltd. romanized | 3 | 1 | 0 |
| 2 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized | 2 | 2 | 2 |
| 3 | Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized | 2 | 2 | 0 |
| 4 | Biohaven Therapeutics Ltd | 2 | 1 | 0 |
| 5 | Shandong An Xin Pharmaceutical Co., Ltd. romanized | 2 | 1 | 2 |
| 6 | Xian Li Jun Pharmaceutical Co., Ltd. romanized | 2 | 1 | 0 |
| 7 | Terumo Corporation Kofu Factory | 1 | 1 | 0 |
| 8 | Shanghai Xian Xiang Pharmaceuticals Technology Co., Ltd. romanized | 1 | 1 | 0 |
| 9 | Huayi Pharmaceuticals (Anhui) Co., Ltd. | 1 | 1 | 1 |
| 10 | Tianjin Shi Zhong Yang Pharma Co., Ltd. romanized | 1 | 1 | 0 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
10 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/01/28Generic · Class 3 | Calcium Acetate Oral SolutionCYHS2500553 | Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/01/28Generic · Class 3 | Oxytocin InjectionCYHS2500550 | Suzhou Tian Ma Pharmaceuticals Group Tian Ji Biopharmaceutical Co., Ltd. romanized |
| 2025/01/28Generic · Class 3 | 碳酸氢钠/葡萄糖2mmol/L钾电解质血滤置换液 · No verified English nameCYHS2500549 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized |
| 2025/01/28Generic · Class 3 | Alendronate Sodium Oral SolutionCYHS2500547 | Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2025/01/28New drug · Class 3.3 | 吸附破伤风疫苗 · No verified English nameCXSS2500022 | Kang Xi Nuo Bio Shareholding Company romanized |
| 2025/01/28New drug · Class 1 | 重组抗人EGFR抗体/IL-10双特异Fc融合蛋白注射液 · No verified English nameCXSL2500098 | Shi Hui Da Pharma Group (Jilin) Co., Ltd. romanized |
| 2025/01/28New drug · Class 1 | 注射用SIM0686 · No verified English nameCXSL2500097 | Shanghai Xian Xiang Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/01/28New drug · Class 1 | BNT327 · No verified English nameCXSL2500096 | Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized; Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized |
| 2025/01/28New drug · Class 1 | BNT326 · No verified English nameCXSL2500095 | Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized; Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized |
| 2025/01/28New drug · Class 1 | HRS-9813胶囊 · No verified English nameCXHL2500147 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
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