YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 426 drug applications between 28 February 2026 and 6 March 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 52, covering 43 drug names.
2026/02/28 – 2026/03/06
- New acceptances this week
- 426
- Drugs with new generic filings (by drug name, de-duplicated)
- 43
- Accepted this week, now under review
- 115
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
426filings, 52 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 247 |
| New drug | 79 |
| Generic | 52 |
| Import | 32 |
| Unspecified | 8 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 211 |
| TCM | 107 |
| Therapeutic biologic | 99 |
| Prophylactic biologic | 5 |
| Biologic | 3 |
| In vitro diagnostic reagent | 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
43 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Cetitizine Hydrochloride Oral Solution | 3 | 1 | 6 |
| 2 | 环硅酸锆钠散 · No verified English name | 2 | 1 | 12 |
| 3 | Rosuvastatin Calcium Tablets | 2 | 1 | 18 |
| 4 | Mirogabalin Besilate Tablets | 2 | 1 | 61 |
| 5 | Dapagliflozin Tablets | 2 | 1 | 84 |
| 6 | Acetate And Glucose Electrolytes Injection | 2 | 1 | 4 |
| 7 | Gadoteridol Injection | 2 | 1 | 3 |
| 8 | Finerenone Tablets | 2 | 1 | 69 |
| 9 | Fluticasone Propionate Cream | 1 | 1 | 12 |
| 10 | Acetylcysteine Injection | 1 | 1 | 53 |
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
236 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bayer Vital GmbH | 16 | 1 | 0 |
| 2 | Hong Ji Tang Pharmaceutical (Lai Wu Qu) Co., Ltd. romanized | 14 | 12 | 0 |
| 3 | Eli Lilly and Company | 9 | 5 | 0 |
| 4 | Amgen Inc. | 9 | 3 | 0 |
| 5 | Nei Menggu Ku Lun Meng Yao Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | Tianjin Hong Ren Tang Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | Shanxi Huang He Zhong Yao Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Shaanxi Pan Long Pharma Group Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Janssen Research & Development LLC | 5 | 3 | 0 |
| 10 | Changchun Jin Sai Pharma Co., Ltd. romanized | 5 | 3 | 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
127 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/03/06Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSS2600020 | MSD International Business GmbH; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2026/03/06Import · Class 2.4 | 贝组替凡片 · No verified English nameJXHS2600030 | MERCK SHARP & DOHME (UK) LIMITED; MSD INTERNATIONAL GMBH; MSD R&D (China) Co. Ltd |
| 2026/03/06Generic · Class 3 | Acetylcysteine TabletsCYHS2600621 | Hebei Rui Sen Pharma Co., Ltd. romanized |
| 2026/03/06Generic · Class 3 | Cetitizine Hydrochloride Oral SolutionCYHS2600618 | Beijing Han Mei Bio Technology Co., Ltd. romanized; Beijing Han Mei Medicines Co., Ltd. romanized |
| 2026/03/06Generic · Class 3 | Cetitizine Hydrochloride Oral SolutionCYHS2600617 | Beijing Han Mei Bio Technology Co., Ltd. romanized; Beijing Han Mei Medicines Co., Ltd. romanized |
| 2026/03/06Generic · Class 3 | Cetitizine Hydrochloride Oral SolutionCYHS2600616 | Beijing Han Mei Bio Technology Co., Ltd. romanized; Beijing Han Mei Medicines Co., Ltd. romanized |
| 2026/03/06Generic · Class 3 | Acetate And Glucose Electrolytes InjectionCYHS2600615 | Chengdu Sai Nuo Lian Chuang Bio Technology Co., Ltd. romanized; Sichuan Tai Ping Yang Pharma Co., Ltd. romanized |
| 2026/03/06Generic · Class 3 | Acetate And Glucose Electrolytes InjectionCYHS2600614 | Chengdu Sai Nuo Lian Chuang Bio Technology Co., Ltd. romanized; Sichuan Tai Ping Yang Pharma Co., Ltd. romanized |
| 2026/03/06New drug · Class 1.1 | 小儿健脾消食颗粒 · No verified English nameCXZL2600026 | Shandong Han Fang Pharmaceutical Co., Ltd. romanized |
| 2026/03/06New drug · Class 1 | SYS6063注射液 · No verified English nameCXSL2600308 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2026/03/06New drug · Class 1 | HSK39297片 · No verified English nameCXHS2600039 | Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized; Hai Si Ke Pharmaceutical (Mei Shan) Co., Ltd. romanized |
| 2026/03/06New drug · Class 1 | GNTbm-38 2HCl 胶囊 · No verified English nameCXHL2600275 | Nuo Wei Tai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/03/06New drug · Class 1 | GNTbm-38 2HCl 胶囊 · No verified English nameCXHL2600274 | Nuo Wei Tai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/03/06New drug · Class 2.4 | TM001 · No verified English nameCXHL2600273 | Haerbin Tian Mei Pharma Co., Ltd. romanized |
| 2026/03/05Import · Class 1 | Pasritamig注射液 · No verified English nameJXSL2600068 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/03/05Import · Class 1 | Pasritamig注射液 · No verified English nameJXSL2600067 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/03/05Import · Class 1 | JNJ-87189401 注射液 · No verified English nameJXSL2600066 | Janssen Research & Development LLC; Johnson & Johnson (China)Investment Ltd. |
| 2026/03/05Import · Class 1 | JNJ-87189401 注射液 · No verified English nameJXSL2600065 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/03/05Generic · Class 3 | Gabapentin Oral SolutionCYHS2600612 | Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized; Shanghai Zhong Hua Pharma Co., Ltd. romanized |
| 2026/03/05New drug · Class 3.1 | 桃红四物汤颗粒 · No verified English nameCXZS2600016 | Shanghai Kai Bao Pharma Co., Ltd. romanized |
| 2026/03/05New drug · Class 3.4 | 人凝血因子Ⅸ · No verified English nameCXSL2600307 | Shenzhen Shi Wei Guang Bio Zhi Pin Co., Ltd. romanized |
| 2026/03/05New drug · Class 1 | 注射用SHR-A2102 · No verified English nameCXSL2600306 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/03/05New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2600305 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/03/05New drug · Class 1 | 注射用SHR-A2009 · No verified English nameCXSL2600304 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/03/05New drug · Class 1 | HS-20117注射液 · No verified English nameCXSL2600303 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2026/03/05New drug · Class 2.4 | 甲磺酸阿美替尼片 · No verified English nameCXHS2600038 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2026/03/05New drug · Class 1 | Alpha-0261片 · No verified English nameCXHL2600272 | Shanghai A Er Fa Fen Zi Qi Ye Development Co., Ltd. romanized |
| 2026/03/05New drug · Class 1 | Alpha-0261片 · No verified English nameCXHL2600271 | Shanghai A Er Fa Fen Zi Qi Ye Development Co., Ltd. romanized |
| 2026/03/04Import · Class 2.2 | Mirikizumab注射液 · No verified English nameJXSL2600064 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2026/03/04Import · Class 2.2 | Mirikizumab注射液 · No verified English nameJXSL2600063 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
97 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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