YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 436 drug applications between 22 February 2026 and 28 February 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 104, covering 78 drug names.
2026/02/22 – 2026/02/28
- New acceptances this week
- 436
- Drugs with new generic filings (by drug name, de-duplicated)
- 78
- Accepted this week, now under review
- 160
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
436filings, 104 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 183 |
| New drug | 105 |
| Generic | 104 |
| Import | 25 |
| Unspecified | 15 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 285 |
| Therapeutic biologic | 89 |
| TCM | 53 |
| Prophylactic biologic | 6 |
| Biologic | 3 |
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
78 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Rosuvastatin Calcium Tablets | 4 | 2 | 18 |
| 2 | Cariprazine hydrochloride Capsules | 3 | 1 | 3 |
| 3 | Fluocinolone Acetonide,Hydroquinone And Tretinoin Cream | 2 | 2 | 1 |
| 4 | Iguratimod Tablets | 2 | 2 | 23 |
| 5 | Tadalafil Tablets | 2 | 1 | 23 |
| 6 | Eplerenone Tablets | 2 | 1 | 4 |
| 7 | Diclofenac Sodium Sustained Release Tablets | 2 | 1 | 10 |
| 8 | Dotinurad Tablets | 2 | 1 | 55 |
| 9 | Cefditoren Pivoxil Granules | 2 | 1 | 18 |
| 10 | Nimodipine Oral Solution | 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
256 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 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized | 7 | 4 | 0 |
| 3 | Novartis Pharma AG | 7 | 3 | 0 |
| 4 | The Wellcome Foundation Limited | 7 | 2 | 0 |
| 5 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | Takeda Development Center Americas Inc. | 6 | 2 | 0 |
| 7 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | 6 | 2 | 0 |
| 8 | Luo Yang Shun Shi Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized | 5 | 4 | 0 |
| 10 | Sichuan Hao Yi Sheng Pan Xi Pharma Co., Ltd. romanized | 5 | 4 | 5 |
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
171 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/02/28Import · Class 1 | JNJ-88549968注射液 · No verified English nameJXSL2600059 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/02/28Import · Class 2.2 | 伊奈利珠单抗注射液 · No verified English nameJXSL2600058 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2026/02/28Generic · Class 3 | Milnacipran Hydrochloride TabletsCYHS2600586 | Zhejiang Hua Bei Pharma Co., Ltd. romanized; Le Pu Pharmaceutical Technology Co., Ltd. romanized |
| 2026/02/28Generic · Class 3 | MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2600584 | Beijing Sheng Yong Pharmaceutical Co., Ltd. romanized |
| 2026/02/28Generic · Class 3 | Potassium Aspartate InjectionCYHS2600583 | Zhejiang Hai Han Pharma Co., Ltd. romanized |
| 2026/02/28Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2600581 | Zhejiang Yi Ze Da Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Zhong Tong Pharma Co., Ltd. romanized |
| 2026/02/28Generic · Class 3 | 聚乙二醇钠钾散 · No verified English nameCYHS2600579 | Hong Yue Technology (Hu Zhou) Co., Ltd. romanized; Hangzhou Qian Yuan Bao Ling Pharma Co., Ltd. romanized |
| 2026/02/28Generic · Class 3 | Mexiletine Hydrochloride TabletsCYHS2600575 | Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized |
| 2026/02/28Generic · Class 3 | Fluocinolone Acetonide,Hydroquinone And Tretinoin CreamCYHL2600032 | Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized |
| 2026/02/28New drug · Class 2.3 | 蒲元和胃胶囊 · No verified English nameCXZL2600024 | Qingdao Hua Ren Tai Pharmaceuticals Ye Co., Ltd. romanized |
| 2026/02/28New drug · Class 1 | CRPA1A2注射液 · No verified English nameCXSL2600286 | Beijing Ke Rui Bio Technology Co., Ltd. romanized |
| 2026/02/28New drug · Class 1 | 注射用HS-20108 · No verified English nameCXSL2600280 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2026/02/28New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2600279 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2026/02/28New drug · Class 1 | SHR-7787注射液 · No verified English nameCXSL2600278 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/02/28New drug · Class 1 | SHR-7787注射液 · No verified English nameCXSL2600277 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/02/28New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2600276 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/02/28New drug · Class 1 | 注射用重组巴曲酶 · No verified English nameCXSL2600275 | Beijing Ge Rui Te Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/02/28New drug · Class 2.2 | QL2107注射液 · No verified English nameCXSL2600273 | Qilu Pharmaceutical Co., Ltd. |
| 2026/02/28New drug · Class 2.2 | 西妥昔单抗β注射液 · No verified English nameCXSL2600272 | Tai Zhou Mai Bo Tai Ke Pharma Co., Ltd. romanized |
| 2026/02/28New drug · Class 1 | SI-B036双特异性抗体注射液 · No verified English nameCXSL2600271 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2026/02/28New drug · Class 1 | DB006溶瘤腺病毒注射液 · No verified English nameCXSL2600270 | Hainan Ji Min Bo Ao International Hospital Co., Ltd. romanized; Guangzhou Da Bo Bio Zhi Pin Co., Ltd. romanized |
| 2026/02/28New drug · Class 1 | 注射用MRG001 · No verified English nameCXSL2600269 | Le Pu Bio Technology Co., Ltd. romanized |
| 2026/02/28New drug · Class 1 | 注射用HDM2017 · No verified English nameCXSL2600268 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2026/02/28New drug · Class 2.3 | 多替拉韦拉米夫定替诺福韦片 · No verified English nameCXHS2600037 | Shanghai Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized |
| 2026/02/28New drug · Class 2.2 | BR170720口服混悬液 · No verified English nameCXHS2600036 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
| 2026/02/28New drug · Class 2.4 | 妥拉美替尼胶囊 · No verified English nameCXHL2600245 | Shanghai Ke Zhou Drug Co., Ltd. romanized |
| 2026/02/28New drug · Class 2.4 | 妥拉美替尼胶囊 · No verified English nameCXHL2600244 | Shanghai Ke Zhou Drug Co., Ltd. romanized |
| 2026/02/27Import · Class 1 | ECI830 · No verified English nameJXHL2600071 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/02/27Import · Class 1 | ECI830 · No verified English nameJXHL2600070 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/02/27Import · Class 1 | ECI830 · No verified English nameJXHL2600069 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
141 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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