YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 266 drug applications between 20 February 2026 and 26 February 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 60, covering 46 drug names.
2026/02/20 – 2026/02/26
- New acceptances this week
- 266
- Drugs with new generic filings (by drug name, de-duplicated)
- 46
- Accepted this week, now under review
- 95
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
266filings, 60 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 110 |
| New drug | 65 |
| Generic | 60 |
| Import | 17 |
| Unspecified | 11 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 179 |
| Therapeutic biologic | 50 |
| TCM | 33 |
| Prophylactic biologic | 4 |
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
46 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tadalafil Tablets | 2 | 1 | 23 |
| 2 | Diclofenac Sodium Sustained Release Tablets | 2 | 1 | 10 |
| 3 | Dotinurad Tablets | 2 | 1 | 55 |
| 4 | Cefditoren Pivoxil Granules | 2 | 1 | 18 |
| 5 | Bumetanide Injection | 2 | 1 | 13 |
| 6 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 2 | 1 | 23 |
| 7 | 氯雷他定糖浆 · No verified English name | 2 | 1 | 7 |
| 8 | Nafamostat Mesilate for Injection | 2 | 1 | 38 |
| 9 | Rosuvastatin Calcium Tablets | 2 | 1 | 18 |
| 10 | Neostigmine Methylsulfate Injection | 2 | 1 | 4 |
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
152 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 7 | 5 | 0 |
| 2 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 6 | 6 | 0 |
| 3 | Takeda Development Center Americas Inc. | 6 | 2 | 0 |
| 4 | Luo Yang Shun Shi Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 4 | 0 |
| 6 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 7 | Sichuan Pharmaceutical Formulations Co., Ltd. romanized | 5 | 2 | 0 |
| 8 | The Wellcome Foundation Limited | 5 | 1 | 0 |
| 9 | Hangzhou Jiu Yuan Ji Yin Biopharmaceuticals Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Guizhou Rui He Pharmaceutical Co., Ltd. romanized | 4 | 4 | 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
103 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/02/26Import · Class 1 | Empasiprubart注射用浓溶液 · No verified English nameJXSL2600057 | argenx BV; PPD Pharmaceutical Development(Beijing)Co.,Ltd. |
| 2026/02/26Import · Class 1 | BMS-986528注射液 · No verified English nameJXSL2600056 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/02/26Generic · Class 3 | 硫酸沙丁胺醇口服溶液 · No verified English nameCYHS2600551 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2026/02/26Generic · Class 3 | Venlafaxine Hydrochloride Extended Release TabletsCYHS2600549 | Nan Tong Lian Ya Pharma Co., Ltd. romanized |
| 2026/02/26Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2600548 | Anhui Jia He Pharma Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2026/02/26Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2600547 | Anhui Jia He Pharma Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2026/02/26Generic · Class 3 | Minoxidil LinimentCYHS2600537 | Hangzhou Wan Bang Tian Cheng Pharma Co., Ltd. romanized |
| 2026/02/26Generic · Class 3 | 维生素K?注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2600533 | Yan Tai Lu Yin Pharma Co., Ltd. romanized |
| 2026/02/26Generic · Class 3 | 维生素K?注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2600531 | Yan Tai Lu Yin Pharma Co., Ltd. romanized |
| 2026/02/26Generic · Class 3 | Bumetanide InjectionCYHS2600530 | Jiangsu Fu Bang Pharma Co., Ltd. romanized |
| 2026/02/26Generic · Class 3 | Bumetanide InjectionCYHS2600529 | Jiangsu Fu Bang Pharma Co., Ltd. romanized |
| 2026/02/26New drug · Class 3.1 | 宣郁通经汤颗粒 · No verified English nameCXZS2600014 | Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized |
| 2026/02/26New drug · Class 1 | 泰利奇拜单抗注射液(皮下注射) · No verified English nameCXSS2600031 | Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized |
| 2026/02/26New drug · Class 1 | 重组抗IL-4Rα人源化单克隆抗体注射液 · No verified English nameCXSS2600030 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2026/02/26New drug · Class 1 | UX-GIP001注射液 · No verified English nameCXSL2600259 | Shanghai Yue Sai Bio Technology Co., Ltd. romanized |
| 2026/02/26New drug · Class 1 | 注射用HS-20122 · No verified English nameCXSL2600256 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2026/02/26New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2600255 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/02/26New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2600254 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/02/26New drug · Class 2.2 | 贝伐珠单抗注射液 · No verified English nameCXSL2600253 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/02/26New drug · Class 1 | 注射用SHR-9839(sc) · No verified English nameCXSL2600252 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/02/26New drug · Class 2.2 | SHR-8068注射液 · No verified English nameCXSL2600251 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/02/26New drug · Class 1 | 注射用SHR-A2102 · No verified English nameCXSL2600250 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized; Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/02/26New drug · Class 1 | 注射用SHR-A2009 · No verified English nameCXSL2600249 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/02/26New drug · Class 1 | 注射用SHR-1826 · No verified English nameCXSL2600248 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/02/26New drug · Class 1 | 注射用FH-006 · No verified English nameCXSL2600247 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Fu Hong Biopharmaceuticals Co., Ltd. romanized |
| 2026/02/26New drug · Class 1 | MY008211A片 · No verified English nameCXHS2600033 | Wuhan Qi Rui Pharma Co., Ltd. romanized |
| 2026/02/26New drug · Class 1 | AHB-171注射液 · No verified English nameCXHL2600240 | Hangzhou Hao Bo Pharmaceuticals Co., Ltd. romanized |
| 2026/02/26New drug · Class 1 | H001片 · No verified English nameCXHL2600236 | Li Zhu Pharmaceuticals Group Co., Ltd. romanized |
| 2026/02/26New drug · Class 1 | QLS7305注射液 · No verified English nameCXHL2600235 | Qilu Pharmaceutical Co., Ltd. |
| 2026/02/26New drug · Class 1 | QLS7305注射液 · No verified English nameCXHL2600234 | Qilu Pharmaceutical Co., Ltd. |
73 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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