YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 362 drug applications between 8 May 2025 and 14 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 99, covering 68 drug names.
2025/05/08 – 2025/05/14
- New acceptances this week
- 362
- Drugs with new generic filings (by drug name, de-duplicated)
- 68
- Accepted this week, now under review
- 42
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
362filings, 99 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 171 |
| Generic | 99 |
| New drug | 65 |
| Import | 20 |
| Unspecified | 6 |
| Import re-registration | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 217 |
| TCM | 70 |
| Therapeutic biologic | 69 |
| Prophylactic biologic | 4 |
| Biologic | 2 |
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
68 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Minoxidil Liniment | 6 | 3 | 52 |
| 2 | Penicillin G Sodium For Injection | 6 | 1 | 2 |
| 3 | Metoclopramide Hydrochloride Injection | 3 | 3 | 6 |
| 4 | Riociguat Tablets | 3 | 1 | 4 |
| 5 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 6 | 氯雷他定糖浆 · No verified English name | 2 | 2 | 7 |
| 7 | 黄体酮注射液(Ⅱ) · No verified English name | 2 | 2 | 2 |
| 8 | Nintedanib Esilate Soft Capsules | 2 | 1 | 6 |
| 9 | Carboplatin Injection | 2 | 1 | 10 |
| 10 | Orlistat Capsules | 2 | 1 | 8 |
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
216 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shenyang Dong Xin Pharma Co., Ltd. romanized | 12 | 12 | 0 |
| 2 | Jiangxi Qing Feng Pharma Co., Ltd. romanized | 10 | 9 | 0 |
| 3 | AstraZeneca AB | 8 | 7 | 0 |
| 4 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 6 | 2 | 0 |
| 5 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 2 | 0 |
| 6 | Sanofi Winthrop Industrie | 6 | 1 | 0 |
| 7 | Chengdu Jing Fu Pharmaceuticals Technology Co., Ltd. romanized | 6 | 1 | 6 |
| 8 | Shanxi Huang He Zhong Yao Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 5 | 4 | 0 |
| 10 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 5 | 3 | 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 |
|---|---|---|
| 2025/05/14Import · Class 3.1 | 达雷妥尤单抗注射液(皮下注射) · No verified English nameJXSS2500061 | Janssen-Cilag International NV; Cilag AG; Johnson & Johnson Pharmaceutical Ltd. |
| 2025/05/14Import · Class 1 | AZD9793 · No verified English nameJXSL2500075 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/05/14Generic · Class 3 | Methocarbamol InjectionCYHS2501745 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2025/05/14Generic · Class 3 | Progesterone InjectionCYHS2501743 | Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/05/14Generic · Class 3 | Bifonazole SolutionCYHS2501742 | Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/05/14Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2501741 | Hainan Ying Da Run Ze Pharma Co., Ltd. romanized; Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized |
| 2025/05/14Generic · Class 3 | Olprinone Hydrochloride InjectionCYHS2501740 | Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized |
| 2025/05/14Generic · Class 3 | Thioctic Acid TabletsCYHS2501735 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2025/05/14Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2501734 | Shenyang Guang Da Pharmaceutical Co., Ltd. romanized; Shenyang Shuang Ding Pharmaceutical Co., Ltd. romanized |
| 2025/05/14Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2501730 | Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2025/05/14Generic · Class 3 | Metronidazole TabletsCYHS2501729 | Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized |
| 2025/05/14Generic · Class 3 | Metronidazole Vaginal GelCYHS2501728 | Hubei Wu Shi Pharma Co., Ltd. romanized |
| 2025/05/14Generic · Class 3 | Relugolix TabletsCYHL2500092 | Jiangsu Lianhuan Pharmaceutical Co.,Ltd. |
| 2025/05/14New drug · Class 1 | 注射用HS-20093 · No verified English nameCXSL2500380 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2025/05/14New drug · Class 1 | SIBP-A16 注射液 · No verified English nameCXSL2500379 | Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2025/05/14New drug · Class 1 | 注射用TQB2103 · No verified English nameCXSL2500378 | Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2025/05/14New drug · Class 1 | TQB2868注射液 · No verified English nameCXSL2500377 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2025/05/14New drug · Class 1 | 吡洛西利片 · No verified English nameCXHS2500051 | Xuan Zhu Bio Technology Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized |
| 2025/05/14New drug · Class 1 | Safusidenib胶囊 · No verified English nameCXHL2500473 | Bao Yuan Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized |
| 2025/05/14New drug · Class 1 | WJ47DZ片 · No verified English nameCXHL2500472 | Nanjing Yi Jing Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/14New drug · Class 1 | WJ47DZ片 · No verified English nameCXHL2500471 | Nanjing Yi Jing Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/14New drug · Class 1 | HRS-5041片 · No verified English nameCXHL2500470 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/05/14New drug · Class 1 | HRS-5041片 · No verified English nameCXHL2500469 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/05/14New drug · Class 1 | HRS-5041片 · No verified English nameCXHL2500468 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/05/14New drug · Class 1 | HRS-2162注射液 · No verified English nameCXHL2500467 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/05/14New drug · Class 1 | HRS-5041片 · No verified English nameCXHL2500466 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/05/14New drug · Class 1 | PTT-501片 · No verified English nameCXHL2500465 | Beijing Yan Ming Bio Technology Co., Ltd. romanized |
| 2025/05/14New drug · Class 1 | PTT-501片 · No verified English nameCXHL2500464 | Beijing Yan Ming Bio Technology Co., Ltd. romanized |
| 2025/05/14New drug · Class 1 | KW-040注射液 · No verified English nameCXHL2500463 | Beijing Kai Yin Technology Co., Ltd. romanized |
| 2025/05/13Import · Class 3.1 | 度普利尤单抗注射液 · No verified English nameJXSS2500060 | Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd. |
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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