YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 265 drug applications between 30 May 2025 and 5 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 79, covering 56 drug names.
2025/05/30 – 2025/06/05
- New acceptances this week
- 265
- Drugs with new generic filings (by drug name, de-duplicated)
- 56
- Accepted this week, now under review
- 48
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
265filings, 79 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 129 |
| Generic | 79 |
| New drug | 42 |
| Import | 7 |
| Import re-registration | 6 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 165 |
| TCM | 60 |
| Therapeutic biologic | 36 |
| Prophylactic biologic | 3 |
| 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
56 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Acetylcysteine Injection | 4 | 4 | 53 |
| 2 | Safinamide Methansulfonate Tablets | 4 | 2 | 20 |
| 3 | Dapagliflozin Tablets | 4 | 2 | 84 |
| 4 | Paliperidone Palmitate Injection | 3 | 1 | 8 |
| 5 | 维生素B6注射液 · No verified English name | 2 | 2 | 10 |
| 6 | Tadalafil Tablets | 2 | 1 | 23 |
| 7 | 利伐沙班颗粒 · No verified English name | 2 | 1 | 2 |
| 8 | 复方氨基酸注射液(20AA-Ⅱ) · No verified English name | 2 | 1 | 0 |
| 9 | 注射用头孢噻肟钠/氯化钠注射液 · No verified English name | 2 | 1 | 2 |
| 10 | Hydrocortisone Sodium Succinate for Injection | 2 | 1 | 16 |
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
179 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized | 10 | 6 | 0 |
| 2 | Guizhou Yi Bai Pharmaceutical Co., Ltd. romanized | 8 | 7 | 0 |
| 3 | Jiangxi Ke Rui Pharma Co., Ltd. romanized | 4 | 3 | 0 |
| 4 | Janssen-Cilag International NV | 4 | 2 | 0 |
| 5 | Li Zhu Group Li Zhu Pharmaceutical Factory romanized | 4 | 2 | 3 |
| 6 | Shaanxi Pan Long Pharma Group Co., Ltd. romanized | 4 | 2 | 0 |
| 7 | Liaoning Hai Shen Lian Sheng Pharmaceutical Co., Ltd. romanized | 4 | 1 | 0 |
| 8 | Jiangsu An Zheng Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 9 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Guizhou De Chang Xiang Pharmaceuticals Co., Ltd. romanized | 3 | 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
76 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/06/05Generic · Class 3 | 注射用头孢噻肟钠/氯化钠注射液 · No verified English nameCYHS2501998 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2025/06/05Generic · Class 3 | 注射用头孢噻肟钠/氯化钠注射液 · No verified English nameCYHS2501997 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2025/06/05Generic · Class 3 | 多种微量元素注射液(Ⅰ) · No verified English nameCYHS2501992 | Chengdu Giantech Hi-technology Development Co., Ltd.; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2025/06/05Generic · Class 3 | Bifonazole SolutionCYHS2501987 | Zhejiang Zhi Xin Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Zhe Bei Pharma Co., Ltd. romanized |
| 2025/06/05Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2501982 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2025/06/05Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2501981 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2025/06/05Generic · Class 3 | Paracetamol and Ibuprofen TabletsCYHS2501980 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.; Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized |
| 2025/06/05New drug · Class 2.1 | 15价肺炎球菌结合疫苗 · No verified English nameCXSS2500059 | Beijing Zhi Fei Lv Zhu Biopharmaceutical Co., Ltd. romanized |
| 2025/06/05New drug · Class 2.2 | 司普奇拜单抗注射液 · No verified English nameCXSL2500454 | Chengdu Kang Nuo Xing Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/06/05New drug · Class 1 | SIBP-A10注射液 · No verified English nameCXSL2500449 | Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2025/06/05New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2500448 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/06/05New drug · Class 2.1 | 替雷利珠单抗注射液(皮下注射) · No verified English nameCXSL2500447 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2025/06/05New drug · Class 1 | KM1溶瘤痘苗病毒注射液 · No verified English nameCXSL2500446 | Shenzhen Shi Hua Yao Kang Ming Bio Pharma Co., Ltd. romanized |
| 2025/06/05New drug · Class 1 | 硫酸索美来昔片 · No verified English nameCXHS2500061 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized |
| 2025/06/05New drug · Class 1 | HB5凝胶 · No verified English nameCXHL2500536 | Beijing Zhong Ke Xian Xing Medical Technology Co., Ltd. romanized; Zhongguo Ke College Li Hua Technology Research Institute romanized |
| 2025/06/05New drug · Class 1 | HB5凝胶 · No verified English nameCXHL2500535 | Beijing Zhong Ke Xian Xing Medical Technology Co., Ltd. romanized; Zhongguo Ke College Li Hua Technology Research Institute romanized |
| 2025/06/05New drug · Class 1 | HB5凝胶 · No verified English nameCXHL2500534 | Beijing Zhong Ke Xian Xing Medical Technology Co., Ltd. romanized; Zhongguo Ke College Li Hua Technology Research Institute romanized |
| 2025/06/05New drug · Class 1 | XC2309注射液 · No verified English nameCXHL2500533 | Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized |
| 2025/06/05New drug · Class 2.2 | 注射用硼[10B]法仑 · No verified English nameCXHL2500532 | Zhong Zi Ke Xue (Chongqing) Research Institute Co., Ltd. romanized |
| 2025/06/05New drug · Class 1 | MDI-1228_mesylate凝胶 · No verified English nameCXHL2500531 | Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized |
| 2025/06/05New drug · Class 1 | MDI-1228_mesylate凝胶 · No verified English nameCXHL2500530 | Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized |
| 2025/06/04Import · Class 2.4 | BMS-986165片 · No verified English nameJXHL2500124 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/06/04Import · Class 2.4 | BMS-986165片 · No verified English nameJXHL2500123 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/06/04Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2501975 | Mu Yuan (Anhui) Pharma Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized |
| 2025/06/04Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2501974 | Mu Yuan (Anhui) Pharma Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized |
| 2025/06/04Generic · Class 3 | Pioglitazone and Metformin Hydrochloride TabletsCYHS2501972 | Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized; Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized |
| 2025/06/04Generic · Class 3 | Sevelamer Carbonate Powder for oral suspensionCYHS2501966 | Fujian Bo Yue Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., Ltd |
| 2025/06/04Generic · Class 3 | Minoxidil LinimentCYHS2501965 | Jiangsu Fu Bang Pharma Co., Ltd. romanized |
| 2025/06/04Generic · Class 3 | Lidocaine and Prilocaine Periodontal GelCYHL2500103 | Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized |
| 2025/06/04New drug · Class 3.1 | 苓桂术甘颗粒 · No verified English nameCXZS2500024 | Shen Wei Pharma Group Co., Ltd. romanized |
46 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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