YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 338 drug applications between 25 November 2025 and 1 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 56 drug names.
2025/11/25 – 2025/12/01
- New acceptances this week
- 338
- Drugs with new generic filings (by drug name, de-duplicated)
- 56
- Accepted this week, now under review
- 86
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
338filings, 70 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 166 |
| Generic | 70 |
| New drug | 61 |
| Import | 24 |
| Unspecified | 14 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 196 |
| TCM | 86 |
| Therapeutic biologic | 50 |
| Biologic | 5 |
| Prophylactic 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 | 复方电解质醋酸钠葡萄糖注射液 · No verified English name | 3 | 2 | 22 |
| 2 | Paliperidone Palmitate Injection | 3 | 1 | 8 |
| 3 | 氢溴酸加兰他敏口崩片 · No verified English name | 3 | 1 | 3 |
| 4 | Crisaborole Ointment | 2 | 2 | 26 |
| 5 | Tacrolimus Ointment | 2 | 1 | 6 |
| 6 | Levonorgestrel Tablets | 2 | 1 | 5 |
| 7 | Empagliflozin Tablets | 2 | 1 | 18 |
| 8 | Loxoprofen Sodium Patches | 2 | 1 | 30 |
| 9 | Levocetirizine dihydrochloride Oral Solution | 2 | 1 | 5 |
| 10 | 磷苯妥英钠注射用浓溶液 · No verified English name | 2 | 1 | 6 |
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
199 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Henan He Zhi Pharmaceuticals Technology Co., Ltd. romanized | 9 | 9 | 0 |
| 2 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 7 | 2 | 0 |
| 3 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 7 | 2 | 1 |
| 4 | Topfond Pharmaceutical Co., Ltd. | 6 | 5 | 2 |
| 5 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized | 6 | 3 | 0 |
| 6 | Rui Li Shi Wan Ting Min Xin Pharmaceutical Co., Ltd. romanized | 6 | 2 | 0 |
| 7 | Novo Nordisk A/S | 6 | 1 | 0 |
| 8 | Guangdong Lei Yun Shang Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Xian Le Xi Medical Technology Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Jin Yao Da Ren Tang Group Co., Ltd. Le Ren Tang Pharmaceutical Factory romanized | 5 | 4 | 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
107 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/12/01Generic · Class 3 | Multiple Electrolytes and Sodium Acetate InjectionCYHS2504127 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2025/12/01Generic · Class 3 | 盐酸西替利嗪滴眼液 · No verified English nameCYHL2500210 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2025/11/29Import · Class 2.2 | 利妥昔单抗注射液 · No verified English nameJXSS2500147 | Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH |
| 2025/11/29Import · Class 2.2 | 利妥昔单抗注射液 · No verified English nameJXSS2500146 | Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH |
| 2025/11/29Import · Class 1 | JNJ-88545223片 · No verified English nameJXHL2500367 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2025/11/29Import · Class 1 | JNJ-88545223片 · No verified English nameJXHL2500366 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2025/11/29Generic · Class 3 | Acetylcysteine TabletsCYHS2504115 | Zhejiang Hao Ge Pharma Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized |
| 2025/11/29Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2504113 | Chongqing He Ping Pharmaceutical Co., Ltd. romanized |
| 2025/11/29Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2504112 | Chongqing He Ping Pharmaceutical Co., Ltd. romanized |
| 2025/11/29Generic · Class 3 | Bromhexine Hydrochloride TabletsCYHS2504110 | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized |
| 2025/11/29Generic · Class 3 | 复方聚乙二醇电解质散(II) · No verified English nameCYHS2504109 | Chongqing Ren Ze Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized |
| 2025/11/29Generic · Class 3 | ω-3甘油三酯(2%)中/长链脂肪乳/氨基酸(16)/葡萄糖(16%)注射液 · No verified English nameCYHS2504108 | Zhejiang Guo Jing Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2025/11/29New drug · Class 2.1; 2.2 | 泰它西普注射液 · No verified English nameCXSL2501028 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2025/11/29New drug · Class 1 | 注射用SSS57 · No verified English nameCXSL2501027 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/11/29New drug · Class 1 | AK139注射液 · No verified English nameCXSL2501026 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2025/11/29New drug · Class 1 | AK139注射液 · No verified English nameCXSL2501025 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2025/11/29New drug · Class 1 | AK139注射液 · No verified English nameCXSL2501024 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2025/11/29New drug · Class 1 | AK139注射液 · No verified English nameCXSL2501023 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2025/11/29New drug · Class 1 | AK139注射液 · No verified English nameCXSL2501022 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2025/11/29New drug · Class 1 | 人自体多克隆调节性T细胞注射液 · No verified English nameCXSL2501020 | Shanghai Sai Er Xin Bio Medical Technology Co., Ltd. romanized |
| 2025/11/29New drug · Class 1 | 注射用SSS57 · No verified English nameCXSL2501019 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/11/29New drug · Class 1 | CMS-D017胶囊 · No verified English nameCXHL2501314 | Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized |
| 2025/11/29New drug · Class 1 | CMS-D017胶囊 · No verified English nameCXHL2501313 | Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized |
| 2025/11/29New drug · Class 1 | CMS-D017胶囊 · No verified English nameCXHL2501312 | Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized |
| 2025/11/29New drug · Class 1 | CMS-D017胶囊 · No verified English nameCXHL2501311 | Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized |
| 2025/11/29New drug · Class 1 | RG002C0106注射液 · No verified English nameCXHL2501310 | Beijing Xuan Jing Rui Pharmaceuticals Technology Co., Ltd. romanized; Suzhou Xuan Jing Bio Technology Co., Ltd. romanized |
| 2025/11/29New drug · Class 1 | 注射用SJ001 · No verified English nameCXHL2501309 | Shanghai Shi Jiang Bio Technology Co., Ltd. romanized |
| 2025/11/29New drug · Class 1 | BEBT-701注射液 · No verified English nameCXHL2501308 | Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized |
| 2025/11/29New drug · Class 2.2 | DP22001口服乳 · No verified English nameCXHL2501307 | Zhongguo Ke College Shanghai Drug Research Institute romanized |
| 2025/11/29New drug · Class 1 | UBT251注射液 · No verified English nameCXHL2501306 | Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized |
77 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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