YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 594 drug applications between 4 February 2026 and 10 February 2026 (data as of 14 November 2026 06:00). Of these, generic applications numbered 92, covering 63 drug names.
2026/02/04 – 2026/02/10
- New acceptances this week
- 594
- Drugs with new generic filings (by drug name, de-duplicated)
- 63
- Accepted this week, now under review
- 148
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
594filings, 92 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 374 |
| Generic | 92 |
| New drug | 81 |
| Import re-registration | 18 |
| Import | 17 |
| Unspecified | 12 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 289 |
| TCM | 229 |
| Therapeutic biologic | 67 |
| Biologic | 6 |
| Prophylactic 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
63 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide Tablets | 5 | 1 | 5 |
| 2 | Crisaborole Ointment | 3 | 2 | 26 |
| 3 | 帕拉米韦氯化钠注射液 · No verified English name | 3 | 2 | 17 |
| 4 | Levofloxacin and Sodium Chloride Injection | 3 | 1 | 14 |
| 5 | Cyclophosphamide Injection | 3 | 1 | 6 |
| 6 | Edoxaban Tosilate Tablets | 3 | 1 | 9 |
| 7 | Ibuprofen Suspension | 2 | 2 | 14 |
| 8 | Ferrous Succinate Tablets | 2 | 2 | 20 |
| 9 | Fluticasone Propionate Cream | 2 | 1 | 12 |
| 10 | Cefditoren Pivoxil Granules | 2 | 1 | 18 |
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
243 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Chongqing Kang Ke Er Pharmaceutical Co., Ltd. romanized | 123 | 95 | 0 |
| 2 | Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | 38 | 19 | 0 |
| 3 | Jiangxi Pu Li Er Pharma Co., Ltd. romanized | 27 | 26 | 0 |
| 4 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 12 | 2 | 0 |
| 5 | Xiu Zheng Pharma Group (Hunan) Pharma Co., Ltd. romanized | 10 | 8 | 0 |
| 6 | AstraZeneca AB | 9 | 5 | 0 |
| 7 | Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized | 8 | 8 | 0 |
| 8 | Guangzhou Wan Yi Te Medical Yong Pin Co., Ltd. romanized | 8 | 5 | 0 |
| 9 | Ai Min Pharma Group Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | PHARMATHEN INVESTMENTS GROUP LIMITED | 5 | 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
128 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/02/10Import · Class 1 | JNJ-79635322 · No verified English nameJXSL2600041 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/02/10Import · Class 1 | JNJ-79635322 · No verified English nameJXSL2600040 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/02/10Import · Class 1 | JNJ-79635322 · No verified English nameJXSL2600039 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/02/10Import · Class 1 | JNJ-79635322 · No verified English nameJXSL2600038 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/02/10Import · Class 1 | TQJ230注射液 · No verified English nameJXHL2600037 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/02/10Import · Class 1 | BIIB115注射液 · No verified English nameJXHL2600036 | Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd |
| 2026/02/10Generic · Class 3 | Fosphenytoin Sodium InjectionCYHS2600430 | Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2026/02/10Generic · Class 3 | Fosphenytoin Sodium InjectionCYHS2600429 | Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2026/02/10Generic · Class 3 | Arformoterol Tartrate Inhalation SolutionCYHS2600423 | HUNAN WARRANT PHARMACEUTICAL CO.,LTD |
| 2026/02/10Generic · Class 3 | 复方聚乙二醇电解质散(Ⅱ) · No verified English nameCYHS2600419 | Hunan Jiudian Pharmaceutical Co., Ltd |
| 2026/02/10Generic · Class 3 | Tetracaine Hydrochloride GelCYHS2600418 | Shanghai Zhao Hui Pharma Co., Ltd. romanized |
| 2026/02/10Generic · Class 3 | MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2600417 | Jiangsu Shen Hua Pharma Co., Ltd. romanized |
| 2026/02/10Generic · Class 3 | Furosemide Oral SolutionCYHS2600415 | Guizhou Qian Yao Group Pharmaceutical Co., Ltd. romanized; Hunan Jia Heng Pharmaceutical Co., Ltd. romanized |
| 2026/02/10Generic · Class 3 | 醋酸地非法林注射液 · No verified English nameCYHL2600022 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized |
| 2026/02/10New drug · Class 2.2 | 重组人血管内皮抑制素注射液 · No verified English nameCXSS2600017 | Shandong Xian Sheng Zai Ming Biopharmaceutical Co., Ltd. romanized |
| 2026/02/10New drug · Class 1 | 注射用PCNAT-01 · No verified English nameCXSL2600201 | An Da Bio Drug Kai Fa (Beijing) Co., Ltd. romanized |
| 2026/02/10New drug · Class 2.2 | 埃诺格鲁肽注射液 · No verified English nameCXSL2600200 | Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized |
| 2026/02/10New drug · Class 2.2 | 埃诺格鲁肽注射液 · No verified English nameCXSL2600199 | Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized |
| 2026/02/10New drug · Class 1 | CPU-YL01注射液 · No verified English nameCXSL2600198 | Jiangsu Chuang Yuan Sheng Ming Technology Co., Ltd. romanized; Zhongguo Yao Ke University romanized |
| 2026/02/10New drug · Class 1 | EA5注射液皮下制剂 · No verified English nameCXSL2600196 | Shanghai Lan Yi Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/02/10New drug · Class 1 | SG301 SC注射液 · No verified English nameCXSL2600195 | Hangzhou Shang Jian Bio Technology Co., Ltd. romanized |
| 2026/02/10New drug · Class 1 | CG001注射液 · No verified English nameCXSL2600194 | Shanghai Kang Jing Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/02/10New drug · Class 1 | ZHB118舌下片 · No verified English nameCXSL2600193 | Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized |
| 2026/02/10New drug · Class 1.4 | 四价重组手足口病疫苗(毕赤酵母) · No verified English nameCXSL2600192 | Chongqing Hua Zhi Biopharmaceutical Co., Ltd. romanized; Hua Song (Shanghai) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/02/10New drug · Class 1 | SSS68注射液 · No verified English nameCXSL2600191 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/02/10New drug · Class 1 | ZHB118舌下片 · No verified English nameCXSL2600190 | Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized |
| 2026/02/10New drug · Class 1 | SSS68注射液 · No verified English nameCXSL2600189 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/02/10New drug · Class 1 | SSS68注射液 · No verified English nameCXSL2600188 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/02/10New drug · Class 1 | 醋酸索乐匹尼布片 · No verified English nameCXHS2600027 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/02/10New drug · Class 2.4 | TXA-070片 · No verified English nameCXHL2600168 | Wuhan Ke Fu Xin Yao Co., Ltd. romanized |
98 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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