YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 347 drug applications between 16 October 2026 and 22 October 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 56, covering 45 drug names.
2026/10/16 – 2026/10/22
- New acceptances this week
- 347
- Drugs with new generic filings (by drug name, de-duplicated)
- 45
- Accepted this week, now under review
- 321
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
347filings, 56 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 188 |
| New drug | 66 |
| Generic | 56 |
| Import | 24 |
| Import re-registration | 10 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 186 |
| TCM | 101 |
| Therapeutic biologic | 55 |
| Biologic | 2 |
| Prophylactic biologic | 2 |
| 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
45 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ruxolitinib Phosphate Tablets | 3 | 1 | 27 |
| 2 | Acetylcysteine Oral Solution | 2 | 1 | 11 |
| 3 | Tacrolimus Sustained-release Capsules | 2 | 1 | 6 |
| 4 | Dotinurad Tablets | 2 | 1 | 55 |
| 5 | 环硅酸锆钠散 · No verified English name | 2 | 1 | 12 |
| 6 | Arginine and Ibuprofen Granules | 2 | 1 | 11 |
| 7 | Bimatoprost Eye Drops | 2 | 1 | 3 |
| 8 | Dapagliflozin Tablets | 2 | 1 | 84 |
| 9 | Zolpidem tartrate extended-release tablets | 2 | 1 | 4 |
| 10 | Avanafil Tablets | 2 | 1 | 2 |
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
228 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Eli Lilly and Company | 13 | 4 | 0 |
| 2 | Hunan Dong Jian Pharma Co., Ltd. romanized | 8 | 8 | 0 |
| 3 | Janssen-Cilag International NV | 6 | 4 | 0 |
| 4 | Shanxi Huang He Zhong Yao Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Medice Arzneimittel Pütter GmbH & Co. KG | 5 | 1 | 0 |
| 6 | Shan Tou Shi Shi Dai Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 4 | 3 | 0 |
| 8 | AbbVie Inc. | 4 | 2 | 0 |
| 9 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 4 | 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
- Entered review this week
- 0
- Left the under-review list this week
- 167
Of these, NMPA published approval-document delivery for 137 (including 130 supplemental applications, not counted as new marketing approvals) and notification delivery for 7; the outcome of the other 23 is to be checked.
Data collected since 2026/10/22: this week counts snapshots from 2026/10/23 only.
Most filings leaving review, by company
| # | Company (first applicant) | Filings | Drugs |
|---|---|---|---|
| 1 | Guangzhou Wang Lao Ji Pharma Co., Ltd. romanized | 4 | 3 |
| 2 | AstraZeneca AB | 4 | 2 |
| 3 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 4 | 1 |
| 4 | Zhejiang Guo Jing Pharma Co., Ltd. romanized | 4 | 1 |
| 5 | Shanghai Kai Bao Xin Yi (Xin Xiang) Pharma Co., Ltd. romanized | 3 | 3 |
| 6 | Sichuan Sheng Tong Yuan Pharmaceutical Group Co., Ltd. romanized | 3 | 3 |
| 7 | Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized | 3 | 2 |
| 8 | Mylan Pharmaceuticals Inc. | 2 | 2 |
| 9 | Shanghai Lei Yun Shang Pharma Co., Ltd. romanized | 2 | 2 |
| 10 | Zhong Shan Shi Heng Sheng Pharma Co., Ltd. romanized | 2 | 2 |
Most filings entering review, by company
No filings entered review this 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
104 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/10/22Generic · Class 3 | Alendronate Sodium Oral SolutionCYHS2602600 | Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/10/22Generic · Class 3 | 艾地骨化醇片 · No verified English nameCYHS2602592 | Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized |
| 2026/10/22Generic · Class 3 | Calcium Gluconate InjectionCYHS2602590 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2026/10/22Generic · Class 3 | lorazepam injectionCYHL2600120 | Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized |
| 2026/10/22New drug · Class 2.5 | 冻干人用狂犬病疫苗(Vero细胞) · No verified English nameCXSL2601165 | Guangzhou Bai Yun Shan Bio Zhi Pin Co., Ltd. romanized |
| 2026/10/22New drug · Class 1 | NK010(冻存制剂)细胞注射液 · No verified English nameCXSL2601164 | Shanghai En Kai Xi Bao Technology Co., Ltd. romanized |
| 2026/10/22New drug · Class 1 | JK06注射液 · No verified English nameCXSL2601163 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2026/10/22New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2601162 | Tianjin He Chuang Bio Technology Co., Ltd. romanized |
| 2026/10/22New drug · Class 1 | CG-0416片 · No verified English nameCXHL2601316 | Shanghai Ke Jun Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Ke Jin Zi Xun Management Co., Ltd. romanized |
| 2026/10/22New drug · Class 1 | CG-0416片 · No verified English nameCXHL2601315 | Shanghai Ke Jun Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Ke Jin Zi Xun Management Co., Ltd. romanized |
| 2026/10/21Import · Class 1 | SAR447998注射用浓溶液 · No verified English nameJXSL2600280 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2026/10/21Import · Class 1 | SAR447998注射用浓溶液 · No verified English nameJXSL2600279 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2026/10/21Import · Class 1 | ABBV-253注射用粉末 · No verified English nameJXSL2600278 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2026/10/21Import · Class 1 | ALXN1720注射液 · No verified English nameJXSL2600277 | Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/10/21Import · Class 2.4 | Momelotinib 片 · No verified English nameJXHL2600460 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Company Limited |
| 2026/10/21Import · Class 2.4 | Momelotinib 片 · No verified English nameJXHL2600459 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Company Limited |
| 2026/10/21Import · Class 2.4 | Momelotinib 片 · No verified English nameJXHL2600458 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Company Limited |
| 2026/10/21Import · Class 1 | DDY391片 · No verified English nameJXHL2600457 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/10/21Import · Class 1 | Ferric Bepectate IV Injection · No verified English nameJXHL2600456 | AFT Pharmaceuticals Ltd |
| 2026/10/21Import · Class 1 | Ferric Bepectate IV Injection · No verified English nameJXHL2600455 | AFT Pharmaceuticals Ltd |
| 2026/10/21Import · Class 1 | Ferric Bepectate IV Injection · No verified English nameJXHL2600454 | AFT Pharmaceuticals Ltd |
| 2026/10/21Generic · Class 3 | Acetylcysteine Oral SolutionCYHS2602584 | Kui Hua Pharma Group (Ji Zhou) Co., Ltd. romanized |
| 2026/10/21Generic · Class 3 | Acetylcysteine Oral SolutionCYHS2602583 | Kui Hua Pharma Group (Ji Zhou) Co., Ltd. romanized |
| 2026/10/21Generic · Class 3 | Zolpidem tartrate extended-release tabletsCYHL2600119 | Xian Yuan Da De Tian Pharma Co., Ltd. romanized |
| 2026/10/21Generic · Class 3 | Zolpidem tartrate extended-release tabletsCYHL2600118 | Xian Yuan Da De Tian Pharma Co., Ltd. romanized |
| 2026/10/21New drug · Class 1.1 | 健骨关节颗粒 · No verified English nameCXZL2600106 | Beijing Yi Ling Pharma Co., Ltd. romanized |
| 2026/10/21New drug · Class 1.1 | JSBCPZ001颗粒 · No verified English nameCXZL2600105 | Beijing Chuang Li Ke Chuang Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2026/10/21New drug · Class 1.1 | 达瓦依鲁克蜜丸 · No verified English nameCXZL2600104 | Xinjiang Wei Wu Er Zi Zhi Qu Wei Wu Er Yi Hospital (Xinjiang Wei Wu Er Zi Zhi Qu Di Er Ren Min Hospital) romanized |
| 2026/10/21New drug · Class 2.3 | 保济口服液 · No verified English nameCXZL2600103 | Guangzhou Wang Lao Ji Pharma Co., Ltd. romanized |
| 2026/10/21New drug · Class 1.1 | 金莲咽扁颗粒 · No verified English nameCXZL2600102 | Guangzhou Bo Ji Xin Yao Lin Chuang Research Center Co., Ltd. romanized |
74 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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