YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 455 drug applications between 5 November 2026 and 11 November 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 83, covering 53 drug names.
2026/11/05 – 2026/11/11
- New acceptances this week
- 455
- Drugs with new generic filings (by drug name, de-duplicated)
- 53
- Accepted this week, now under review
- 455
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
455filings, 83 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 245 |
| Generic | 83 |
| New drug | 73 |
| Import | 47 |
| Import re-registration | 6 |
| Unspecified | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 258 |
| TCM | 104 |
| Therapeutic biologic | 90 |
| Prophylactic biologic | 2 |
| 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
53 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dotinurad Tablets | 4 | 2 | 55 |
| 2 | Ibuprofen Injection | 4 | 2 | 8 |
| 3 | Mirogabalin Besilate Tablets | 4 | 2 | 61 |
| 4 | Ertugliflozin Tablets | 3 | 3 | 13 |
| 5 | Brivaracetam Tablets | 3 | 1 | 19 |
| 6 | Piperacillin Sodium for Injection | 3 | 1 | 16 |
| 7 | Fosfomycin Sodium For Injection | 3 | 1 | 16 |
| 8 | Edaravone and Dexborneol Concentrated Solution for Injection | 2 | 2 | 34 |
| 9 | Ethyl Iosapentate Capsules | 2 | 1 | 27 |
| 10 | Oxaliplatin Injection | 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
280 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | F. Hoffmann-La Roche Ltd | 8 | 2 | 0 |
| 2 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 7 | 3 | 0 |
| 3 | Amgen Inc. | 7 | 2 | 0 |
| 4 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 6 | 5 | 0 |
| 5 | Pfizer Inc. | 6 | 3 | 0 |
| 6 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | AstraZeneca AB | 5 | 3 | 0 |
| 8 | Chengdu Shuo De Pharma Co., Ltd. romanized | 5 | 3 | 1 |
| 9 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 5 | 2 | 3 |
| 10 | MyoKardia Inc. | 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
- Entered review this week
- 477
- Left the under-review list this week
- 494
Of these, NMPA published approval-document delivery for 238 (including 224 supplemental applications, not counted as new marketing approvals) and notification delivery for 8; the outcome of the other 248 is to be checked.
Most filings leaving review, by company
| # | Company (first applicant) | Filings | Drugs |
|---|---|---|---|
| 1 | Rui Li Shi Wan Ting Min Xin Pharmaceutical Co., Ltd. romanized | 11 | 2 |
| 2 | AstraZeneca AB | 6 | 4 |
| 3 | Sichuan Pharmaceutical Formulations Co., Ltd. romanized | 6 | 3 |
| 4 | Liaoning Min Kang Pharmaceutical Co., Ltd. romanized | 6 | 2 |
| 5 | Novo Nordisk A/S | 5 | 1 |
| 6 | Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 4 | 4 |
| 7 | Sichuan Tai Le Pharmaceutical Co., Ltd. romanized | 4 | 4 |
| 8 | Hubei Dong Xin Pharma Co., Ltd. romanized | 4 | 4 |
| 9 | Merck Sharp & Dohme LLC | 4 | 3 |
| 10 | Guangzhou Nuo Jin Pharmaceutical Co., Ltd. romanized | 4 | 3 |
Most filings entering review, by company
| # | Company (first applicant) | Filings | Drugs |
|---|---|---|---|
| 1 | Amgen Inc. | 12 | 3 |
| 2 | Novo Nordisk A/S | 10 | 1 |
| 3 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 6 | 5 |
| 4 | Pfizer Inc. | 6 | 3 |
| 5 | F. Hoffmann-La Roche Ltd | 6 | 1 |
| 6 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 6 | 1 |
| 7 | AstraZeneca AB | 5 | 3 |
| 8 | Chengdu Shuo De Pharma Co., Ltd. romanized | 5 | 3 |
| 9 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 5 | 2 |
| 10 | MyoKardia Inc. | 5 | 1 |
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
144 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/11/11Import · Class 1 | RO7497372 注射液 · No verified English nameJXSL2600313 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/11/11Import · Class 1 | RO7497372 注射液 · No verified English nameJXSL2600312 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/11/11Import · Class 1 | Verve-102注射液 · No verified English nameJXSL2600311 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/11/11Import · Class 1 | PF-08653945注射液 · No verified English nameJXHL2600506 | Pfizer Inc.; Pfizer(Beijing)Research and Development Co. Ltd. |
| 2026/11/11Generic · Class 3 | Fosfomycin Sodium For InjectionCYHS2602780 | Zhejiang AngLiKang Pharmaceutical CO.,LTD.; Zhejiang Zhe Bei Pharma Co., Ltd. romanized |
| 2026/11/11Generic · Class 3 | Fosfomycin Sodium For InjectionCYHS2602779 | Zhejiang AngLiKang Pharmaceutical CO.,LTD.; Zhejiang Zhe Bei Pharma Co., Ltd. romanized |
| 2026/11/11Generic · Class 3 | Fosfomycin Sodium For InjectionCYHS2602778 | Zhejiang AngLiKang Pharmaceutical CO.,LTD.; Zhejiang Zhe Bei Pharma Co., Ltd. romanized |
| 2026/11/11Generic · Class 3 | Ibuprofen InjectionCYHS2602772 | Zhengzhou Zhuo Feng Pharmaceutical Co., Ltd. romanized |
| 2026/11/11Generic · Class 3 | Ibuprofen InjectionCYHS2602771 | Zhengzhou Zhuo Feng Pharmaceutical Co., Ltd. romanized |
| 2026/11/11Generic · Class 3 | 右美托咪定舌下膜 · No verified English nameCYHL2600129 | Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/11/11Generic · Class 3 | Fluocinolone Acetonide,Hydroquinone And Tretinoin CreamCYHL2600128 | Zhejiang Hao Ge Pharma Co., Ltd. romanized |
| 2026/11/11New drug · Class 1.1 | 轻身调脂消渴片 · No verified English nameCXZL2600115 | Jiangsu Jiu Xu Pharma Co., Ltd. romanized; Zhongguo Zhong Yi Ke College Guang An Men Hospital romanized |
| 2026/11/11New drug · Class 1 | LYW2402-NS-HK人源基质细胞注射液(三维工艺制备) · No verified English nameCXSL2601253 | Liaoning Yi Xue Zhen Liao Technology Research and Development Center Co., Ltd. romanized |
| 2026/11/11New drug · Class 1 | 注射用HS-20093 · No verified English nameCXSL2601252 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2026/11/11New drug · Class 2.3 | 比索洛尔左氨氯地平片 · No verified English nameCXHS2600153 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2026/11/11New drug · Class 1 | HRS-7172片 · No verified English nameCXHL2601409 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/11/11New drug · Class 1 | HRS-7172片 · No verified English nameCXHL2601408 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/11/11New drug · Class 1 | HRS-7172片 · No verified English nameCXHL2601407 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/11/11New drug · Class 1 | LW402片 · No verified English nameCXHL2601406 | Shanghai Zhang Sen Pharma Co., Ltd. romanized |
| 2026/11/11New drug · Class 1 | LW402片 · No verified English nameCXHL2601405 | Shanghai Zhang Sen Pharma Co., Ltd. romanized |
| 2026/11/11New drug · Class 1 | IG001119片 · No verified English nameCXHL2601404 | Yang Guang An Jin (Nanjing) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/11/11New drug · Class 1 | IG001119片 · No verified English nameCXHL2601403 | Yang Guang An Jin (Nanjing) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/11/11New drug · Class 1 | HRS-4642注射液 · No verified English nameCXHL2601402 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/11/11New drug · Class 1 | JMKX003948片 · No verified English nameCXHL2601401 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized |
| 2026/11/11New drug · Class 1 | JMKX003948片 · No verified English nameCXHL2601400 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized |
| 2026/11/11New drug · Class 1 | JMKX003948片 · No verified English nameCXHL2601399 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized |
| 2026/11/11New drug · Class 1 | HRS-2329片 · No verified English nameCXHL2601398 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/11/11New drug · Class 1 | HRS-2329片 · No verified English nameCXHL2601397 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/11/11New drug · Class 1 | HRS-6093片 · No verified English nameCXHL2601396 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/11/11New drug · Class 1 | HRS-6093片 · No verified English nameCXHL2601395 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
114 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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