YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 398 drug applications between 31 August 2025 and 6 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 113, covering 75 drug names.
2025/08/31 – 2025/09/06
- New acceptances this week
- 398
- Drugs with new generic filings (by drug name, de-duplicated)
- 75
- Accepted this week, now under review
- 121
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
398filings, 113 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 167 |
| Generic | 113 |
| New drug | 78 |
| Import | 29 |
| Unspecified | 6 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 262 |
| TCM | 70 |
| Therapeutic biologic | 61 |
| Biologic | 4 |
| 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
75 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sacubitril Valsartan Sodium Tablets | 8 | 3 | 70 |
| 2 | Polidocanol Injection | 4 | 2 | 23 |
| 3 | Ozagrel Sodium Injection | 3 | 1 | 3 |
| 4 | 左羟丙哌嗪口服溶液 · No verified English name | 3 | 1 | 8 |
| 5 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 6 | Pemafibrate Tablets | 2 | 2 | 23 |
| 7 | Ceftazidime And Avibactam Sodium For Injection | 2 | 2 | 12 |
| 8 | Rivaroxaban Tablets | 2 | 1 | 3 |
| 9 | Diclofenac Diethylamine Emulgel | 2 | 1 | 20 |
| 10 | 复方醋酸钠葡萄糖注射液 · No verified English name | 2 | 1 | 8 |
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
232 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized | 11 | 2 | 0 |
| 2 | Qilu Pharmaceutical Co., Ltd. | 10 | 5 | 2 |
| 3 | Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized | 9 | 7 | 0 |
| 4 | Topfond Pharmaceutical Co., Ltd. | 8 | 8 | 0 |
| 5 | Eli Lilly and Company | 8 | 2 | 0 |
| 6 | Janssen Research & Development LLC | 6 | 2 | 0 |
| 7 | Shandong Jian Bin Pharmaceuticals Technology Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Hubei Ke Lun Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 4 | 2 | 4 |
| 10 | Shanghai Ao Ke Da Pharmaceuticals Technology Co., Ltd. romanized | 4 | 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
148 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/09/06Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSS2500122 | MSD International Business GmbH; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2025/09/06Import · Class 1 | FUB523注射液 · No verified English nameJXSL2500169 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/09/06Generic · Class 3 | 复方醋酸钠葡萄糖注射液 · No verified English nameCYHS2503313 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2025/09/06Generic · Class 3 | 复方醋酸钠葡萄糖注射液 · No verified English nameCYHS2503312 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2025/09/06Generic · Class 3 | Tiopronin TabletsCYHS2503304 | Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/09/06Generic · Class 3 | Relugolix TabletsCYHL2500162 | Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2025/09/06New drug · Class 1.1 | 小儿六味湿疹凝胶 · No verified English nameCXZL2500075 | Shandong Han Fang Pharmaceutical Co., Ltd. romanized |
| 2025/09/06New drug · Class 2.2 | 信迪利单抗注射液 · No verified English nameCXSL2500774 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/09/06New drug · Class 1 | TQB2922注射液(皮下注射) · No verified English nameCXSL2500773 | Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2025/09/06New drug · Class 1 | ESG206注射液 · No verified English nameCXSL2500772 | Shanghai Shi Jian Bio Technology Co., Ltd. romanized |
| 2025/09/06New drug · Class 1 | 注射用间充质干细胞(脐带) · No verified English nameCXSL2500771 | Tianjin Ang Sai Xi Bao Ji Yin Gong Cheng Co., Ltd. romanized |
| 2025/09/06New drug · Class 1 | HWS117注射液 · No verified English nameCXSL2500770 | Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized |
| 2025/09/06New drug · Class 1 | 注射用ZG006 · No verified English nameCXSL2500769 | Name not romanized; Name not romanized |
| 2025/09/06New drug · Class 1 | IBI3033 · No verified English nameCXSL2500768 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/09/06New drug · Class 1 | IBI3033 · No verified English nameCXSL2500767 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/09/06New drug · Class 1 | GW5282片 · No verified English nameCXHL2500970 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized |
| 2025/09/06New drug · Class 1 | GW5282片 · No verified English nameCXHL2500969 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized |
| 2025/09/06New drug · Class 1 | GS3-007a干混悬剂 · No verified English nameCXHL2500968 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2025/09/06New drug · Class 1 | QLS1304片 · No verified English nameCXHL2500967 | Qilu Pharmaceutical Co., Ltd. |
| 2025/09/06New drug · Class 1 | QLS1304片 · No verified English nameCXHL2500966 | Qilu Pharmaceutical Co., Ltd. |
| 2025/09/06New drug · Class 1 | QLS1304片 · No verified English nameCXHL2500965 | Qilu Pharmaceutical Co., Ltd. |
| 2025/09/06New drug · Class 1 | QLC1401片 · No verified English nameCXHL2500964 | Qilu Pharmaceutical Co., Ltd. |
| 2025/09/06New drug · Class 2.4 | 阿贝西利片 · No verified English nameCXHL2500963 | Qilu Pharmaceutical Co., Ltd. |
| 2025/09/06New drug · Class 2.4 | 阿贝西利片 · No verified English nameCXHL2500962 | Qilu Pharmaceutical Co., Ltd. |
| 2025/09/06New drug · Class 2.4 | 阿贝西利片 · No verified English nameCXHL2500961 | Qilu Pharmaceutical Co., Ltd. |
| 2025/09/06New drug · Class 1 | VSA012注射液 · No verified English nameCXHL2500960 | Wei Ya Zhen Bio Technology (Suzhou) Co., Ltd. romanized |
| 2025/09/05Import · Class 3.1 | 注射用伏索利肽 · No verified English nameJXSS2500121 | BioMarin International Limited; Vetter Pharma-Fertigung GmbH & Co. KG; PAREXEL China Co. Ltd |
| 2025/09/05Import · Class 3.1 | 注射用伏索利肽 · No verified English nameJXSS2500120 | BioMarin International Limited; Vetter Pharma-Fertigung GmbH & Co. KG; PAREXEL China Co. Ltd |
| 2025/09/05Import · Class 3.1 | 注射用伏索利肽 · No verified English nameJXSS2500119 | BioMarin International Limited; Vetter Pharma-Fertigung GmbH & Co. KG; PAREXEL China Co. Ltd |
| 2025/09/05Import · Class 1 | ACE1831 · No verified English nameJXSL2500168 | Acepodia Biotech Inc.; Syneos Health(Beijing)Inc. Ltd. |
118 more not listed (at most 30 rows).
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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