YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 338 drug applications between 21 January 2026 and 27 January 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 57, covering 42 drug names.
2026/01/21 – 2026/01/27
- New acceptances this week
- 338
- Drugs with new generic filings (by drug name, de-duplicated)
- 42
- Accepted this week, now under review
- 80
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
338filings, 57 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 166 |
| New drug | 78 |
| Generic | 57 |
| Import | 20 |
| Unspecified | 11 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 215 |
| Therapeutic biologic | 67 |
| TCM | 51 |
| In vitro diagnostic reagent | 2 |
| Biologic | 2 |
| 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
42 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 醋酸艾司利卡西平片 · No verified English name | 4 | 1 | 4 |
| 2 | Perindopril tert-Butylamine Tablets | 2 | 1 | 5 |
| 3 | 复方氨基酸注射液(17AA-Ⅲ) · No verified English name | 2 | 1 | 2 |
| 4 | Nimodipine Oral Solution | 2 | 1 | 4 |
| 5 | Budesonide Nasal Spray | 2 | 1 | 3 |
| 6 | Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation | 2 | 1 | 12 |
| 7 | Phenylephrine Hydrochloride Injection | 2 | 1 | 5 |
| 8 | Bromhexine Hydrochloride Oral Solution | 2 | 1 | 22 |
| 9 | Ziprasidone Hydrochloride Capsules | 2 | 1 | 9 |
| 10 | Minoxidil Liniment | 2 | 1 | 52 |
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
193 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shaanxi Pharmaceuticals Holding Group Bio Zhi Pin (Han Zhong) Co., Ltd. romanized | 9 | 7 | 0 |
| 2 | Kashima Plant Eisai Co. Ltd. | 6 | 6 | 0 |
| 3 | Pfizer Inc. | 6 | 3 | 0 |
| 4 | Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized | 6 | 3 | 0 |
| 5 | Novo Nordisk A/S | 6 | 2 | 0 |
| 6 | Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Novartis Pharma AG | 5 | 4 | 0 |
| 8 | Sanofi Winthrop Industrie | 4 | 3 | 0 |
| 9 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 4 | 2 | 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
116 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/01/27Import · Class 2.2 | N-803 · No verified English nameJXSL2600025 | ImmunityBio Inc.; Hangzhou Tigermed Consulting Co. Ltd |
| 2026/01/27Generic · Class 3 | Minoxidil LinimentCYHS2600286 | Shandong Jian Bin Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized |
| 2026/01/27Generic · Class 3 | Minoxidil LinimentCYHS2600285 | Shandong Jian Bin Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized |
| 2026/01/27Generic · Class 3 | Emedastine Difumarate Sustained-release CapsulesCYHS2600284 | Hainan Mei Kang Da Pharma Co., Ltd. romanized; Sichuan De Feng Pharma Co., Ltd. romanized |
| 2026/01/27New drug · Class 1.1 | XKZ2305颗粒 · No verified English nameCXZL2600013 | Lian Cheng Xun Kang (Zhuhai Heng Qin) Pharma Co., Ltd. romanized |
| 2026/01/27New drug · Class 1 | AZD0305 · No verified English nameCXSL2600134 | A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized |
| 2026/01/27New drug · Class 1 | 注射用SSGJ-612 · No verified English nameCXSL2600133 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/01/27New drug · Class 1 | 注射用SSGJ-705 · No verified English nameCXSL2600132 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/01/27New drug · Class 1 | BNT326 · No verified English nameCXSL2600131 | Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized; Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized |
| 2026/01/27New drug · Class 1 | BNT327 · No verified English nameCXSL2600130 | Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2026/01/27New drug · Class 1 | BBT001皮下注射液 · No verified English nameCXSL2600128 | Shan Zhu Yao (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/01/27New drug · Class 1 | BBT001皮下注射液 · No verified English nameCXSL2600127 | Shan Zhu Yao (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/01/27New drug · Class 2.2; 2.4 | LP注射液 · No verified English nameCXHL2600128 | Shenzhen Peng Jia Pharmaceuticals Technology Co., Ltd. romanized; Shenzhen Bo Rui Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/01/27New drug · Class 1 | 苯磺酸CG-0255胶囊 · No verified English nameCXHL2600127 | Shanghai Ke Jun Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Ke Jin Zi Xun Management Co., Ltd. romanized |
| 2026/01/27New drug · Class 2.4 | JP-1366片 · No verified English nameCXHL2600126 | Li Zhu Pharmaceuticals Group Co., Ltd. romanized |
| 2026/01/27New drug · Class 1 | TQB3205胶囊 · No verified English nameCXHL2600125 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2026/01/27New drug · Class 1 | TQB3205胶囊 · No verified English nameCXHL2600124 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2026/01/26Generic · Class 3 | Lansoprazole For InjectionCYHS2600280 | Shanxi De Yuan Tang Pharma Co., Ltd. romanized |
| 2026/01/26Generic · Class 3 | 小儿复方氨基酸注射液(20AA) · No verified English nameCYHS2600276 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2026/01/26New drug · Class 1 | BG-A3004注射液 · No verified English nameCXSL2600129 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2026/01/26New drug · Class 1 | EA5注射液皮下制剂 · No verified English nameCXSL2600126 | Shandong Lan Yi Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Lan Yi Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/01/26New drug · Class 2.1; 2.2 | 泰它西普注射液 · No verified English nameCXSL2600125 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2026/01/26New drug · Class 1 | BCR-0003片 · No verified English nameCXHL2600123 | Zhejiang Zhong Shen Innovation Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/01/26New drug · Class 1 | BCR-0003片 · No verified English nameCXHL2600122 | Zhejiang Zhong Shen Innovation Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/01/26New drug · Class 1 | DC561043片 · No verified English nameCXHL2600121 | Zhongguo Ke College Shanghai Drug Research Institute romanized; Lin Gang Guo Jia Laboratory romanized |
| 2026/01/24Generic · Class 3 | 醋酸艾司利卡西平片 · No verified English nameCYHS2600270 | Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized; Changzhou Pharmaceutical Factory Co., Ltd. romanized |
| 2026/01/24Generic · Class 3 | 醋酸艾司利卡西平片 · No verified English nameCYHS2600269 | Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized; Changzhou Pharmaceutical Factory Co., Ltd. romanized |
| 2026/01/24Generic · Class 3 | 醋酸艾司利卡西平片 · No verified English nameCYHS2600268 | Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized; Changzhou Pharmaceutical Factory Co., Ltd. romanized |
| 2026/01/24Generic · Class 3 | 醋酸艾司利卡西平片 · No verified English nameCYHS2600267 | Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized; Changzhou Pharmaceutical Factory Co., Ltd. romanized |
| 2026/01/24New drug · Class 1 | RSS0393乳胶 · No verified English nameCXHL2600120 | Rui Shi Biopharmaceuticals Co., Ltd. romanized |
86 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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