YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 396 drug applications between 11 May 2024 and 17 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 94, covering 67 drug names.
2024/05/11 – 2024/05/17
- New acceptances this week
- 396
- Drugs with new generic filings (by drug name, de-duplicated)
- 67
- Accepted this week, now under review
- 5
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
396filings, 94 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 169 |
| Generic | 94 |
| New drug | 85 |
| Import | 24 |
| Import re-registration | 16 |
| Unspecified | 5 |
| Drug-device combination product | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 276 |
| Therapeutic biologic | 66 |
| TCM | 44 |
| Prophylactic biologic | 7 |
| Drug-device combination | 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
67 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 3 | 2 | 60 |
| 2 | Sacubitril Valsartan Sodium Tablets | 3 | 2 | 70 |
| 3 | Benidipine Hydrochloride Tablets | 3 | 2 | 4 |
| 4 | Sildenafil Citrate Tablets | 3 | 1 | 12 |
| 5 | Nicorandil for Injection | 3 | 1 | 1 |
| 6 | Famotidine Injection | 2 | 2 | 8 |
| 7 | Phenylephrine Hydrochloride Injection | 2 | 2 | 5 |
| 8 | Glyburide and Metformin Hydrochloride Tablets | 2 | 1 | 0 |
| 9 | Tacrolimus Sustained-release Capsules | 2 | 1 | 6 |
| 10 | 利伐沙班干混悬剂 · No verified English name | 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
222 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Heng Xing Technology Pharmaceutical Co., Ltd. romanized | 17 | 16 | 0 |
| 2 | Anhui Feng Yuan Pharma Co., Ltd. Huai Hai Pharmaceutical Factory romanized | 10 | 2 | 0 |
| 3 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 7 | 2 | 0 |
| 4 | Pfizer Inc. | 6 | 3 | 0 |
| 5 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 6 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 5 | 4 | 5 |
| 8 | Hainan Huluwa Pharmaceutical Group Co., Ltd. | 5 | 3 | 5 |
| 9 | Janssen Research & Development LLC | 5 | 2 | 0 |
| 10 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD. | 5 | 2 | 5 |
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
139 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/05/17Import · Class 1 | 注射用M9140 · No verified English nameJXSL2400096 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd. |
| 2024/05/17Import · Class 2.2 | Dostarlimab注射液 · No verified English nameJXSL2400095 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. LTD |
| 2024/05/17Import · Class 2.2 | Dostarlimab注射液 · No verified English nameJXSL2400094 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd. |
| 2024/05/17Import · Class 1 | Amlitelimab注射液 · No verified English nameJXSL2400093 | Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD |
| 2024/05/17Generic · Class 3 | Amisulpride InjectionCYHS2401488 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD. |
| 2024/05/17Generic · Class 3 | Amisulpride InjectionCYHS2401487 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD. |
| 2024/05/17Generic · Class 3 | Bumetanide InjectionCYHS2401480 | Sichuan Ao Bang Gu De Pharma Co., Ltd. romanized; Chengdu Li Er Pharma Co., Ltd. romanized |
| 2024/05/17Generic · Class 3 | 盐酸纳美芬注射液 · No verified English nameCYHS2401479 | Hainan Ai Ke Pharmaceutical Co., Ltd. romanized |
| 2024/05/17Generic · Class 3 | Metaraminol Tartrate InjectionCYHS2401477 | Guangzhou Hui Feng De Bio Technology Co., Ltd. romanized; Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized |
| 2024/05/17Generic · Class 3 | Glyburide and Metformin Hydrochloride TabletsCYHS2401476 | Tong Hua Wan Tong Pharma Co., Ltd. romanized |
| 2024/05/17Generic · Class 3 | Glyburide and Metformin Hydrochloride TabletsCYHS2401475 | Tong Hua Wan Tong Pharma Co., Ltd. romanized |
| 2024/05/17Generic · Class 3 | Diprophylline InjectionCYHS2401474 | E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized |
| 2024/05/17Generic · Class 3 | Peramivir InjectionCYHS2401473 | Zhejiang Kang Ji Er Pharma Co., Ltd. romanized |
| 2024/05/17Generic · Class 3 | Pentoxifylline Modified Release TabletsCYHS2401472 | Jewim Pharmaceutical (Shandong) Co., Ltd. |
| 2024/05/17New drug · Class 3.1 | 二冬颗粒 · No verified English nameCXZS2400016 | Guizhou Wei Men Pharma Co., Ltd. romanized |
| 2024/05/17New drug · Class 1 | 注射用重组WNV-HCD86 · No verified English nameCXSL2400329 | Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized |
| 2024/05/17New drug · Class 1 | 注射用重组WNV-HCD86 · No verified English nameCXSL2400328 | Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized |
| 2024/05/17New drug · Class 1 | 注射用重组WNV-HCD86 · No verified English nameCXSL2400327 | Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized |
| 2024/05/17New drug · Class 1 | 注射用重组WNV-HCD86 · No verified English nameCXSL2400326 | Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized |
| 2024/05/17New drug · Class 1 | 注射用重组WNV-HCD86 · No verified English nameCXSL2400325 | Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized |
| 2024/05/17New drug · Class 1 | IBI3004 · No verified English nameCXSL2400324 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2024/05/17New drug · Class 1 | ZL-82片 · No verified English nameCXHL2400510 | Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/05/17New drug · Class 1 | ZL-82片 · No verified English nameCXHL2400509 | Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/05/17New drug · Class 1 | ZL-82片 · No verified English nameCXHL2400508 | Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/05/17New drug · Class 1 | KY-001 · No verified English nameCXHL2400507 | Shanghai Qi Zhen Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/05/17New drug · Class 1 | KY-001 · No verified English nameCXHL2400506 | Shanghai Qi Zhen Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/05/17New drug · Class 2.4 | 恩那度司他片 · No verified English nameCXHL2400505 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2024/05/17New drug · Class 2.4 | 恩那度司他片 · No verified English nameCXHL2400504 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2024/05/17New drug · Class 2.4 | 恩那度司他片 · No verified English nameCXHL2400503 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2024/05/17New drug · Class 2.4 | 恩那度司他片 · No verified English nameCXHL2400502 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
109 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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