YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 365 drug applications between 26 November 2025 and 2 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 78, covering 61 drug names.
2025/11/26 – 2025/12/02
- New acceptances this week
- 365
- Drugs with new generic filings (by drug name, de-duplicated)
- 61
- Accepted this week, now under review
- 92
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
365filings, 78 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 187 |
| Generic | 78 |
| New drug | 62 |
| Import | 22 |
| Unspecified | 14 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 216 |
| TCM | 90 |
| Therapeutic biologic | 53 |
| 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
61 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Paliperidone Palmitate Injection | 3 | 1 | 8 |
| 2 | 氢溴酸加兰他敏口崩片 · No verified English name | 3 | 1 | 3 |
| 3 | Pemafibrate Tablets | 2 | 2 | 23 |
| 4 | Crisaborole Ointment | 2 | 2 | 26 |
| 5 | Tacrolimus Ointment | 2 | 1 | 6 |
| 6 | 复方电解质醋酸钠葡萄糖注射液 · No verified English name | 2 | 1 | 22 |
| 7 | Levonorgestrel Tablets | 2 | 1 | 5 |
| 8 | Empagliflozin Tablets | 2 | 1 | 18 |
| 9 | Teneligliptin Hydrobromide Hydrate Tablets | 2 | 1 | 10 |
| 10 | Levocetirizine dihydrochloride Oral Solution | 2 | 1 | 5 |
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 | Henan He Zhi Pharmaceuticals Technology Co., Ltd. romanized | 9 | 9 | 0 |
| 2 | Novo Nordisk A/S | 9 | 2 | 0 |
| 3 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 7 | 2 | 1 |
| 4 | Rui Li Shi Wan Ting Min Xin Pharmaceutical Co., Ltd. romanized | 6 | 2 | 0 |
| 5 | Xian Le Xi Medical Technology Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Beijing Sai Er Bio Pharma Co., Ltd. romanized | 5 | 4 | 5 |
| 7 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized | 5 | 1 | 0 |
| 8 | Guangzhou Bai Yun Shan Hua Cheng Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Merck Sharp & Dohme LLC | 4 | 3 | 0 |
| 10 | Topfond Pharmaceutical Co., Ltd. | 4 | 3 | 2 |
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
106 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/12/02Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2504138 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/12/02Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2504126 | Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized |
| 2025/12/02Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2504125 | Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized |
| 2025/12/02Generic · Class 3 | MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2504121 | Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanized |
| 2025/12/02Generic · Class 3 | Nafamostat Mesilate for InjectionCYHL2500211 | Tianjin Hong Ri Pharma Co., Ltd. romanized |
| 2025/12/02New drug · Class 1.1 | 疏肝解郁颗粒 · No verified English nameCXZS2500048 | Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized; Kang Mei Bao Ning (Sichuan) Pharmaceutical Co., Ltd. romanized |
| 2025/12/02New drug · Class 1.1 | 黑黄赤珠颗粒 · No verified English nameCXZL2500124 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2025/12/02New drug · Class 2.3 | 血府逐瘀口服液 · No verified English nameCXZL2500123 | Shandong Hong Ji Tang Pharmaceutical Group Co., Ltd. romanized |
| 2025/12/02New drug · Class 1 | BPAb002注射液 · No verified English nameCXSL2501032 | Bo Pin Ze Rong (Shenzhen) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/02New drug · Class 1 | VERT-002注射液 · No verified English nameCXSL2501031 | Pi Er Fa Bo (Shanghai) Medical Technology Co., Ltd. romanized |
| 2025/12/02New drug · Class 1 | HT-102注射液 · No verified English nameCXSL2501030 | Suzhou Xing Yao Kun Ze Biopharmaceutical Co., Ltd. romanized; An Ji Xing Yao Kun Ze Biopharmaceutical Co., Ltd. romanized |
| 2025/12/02New drug · Class 1 | 注射用GQ1001冻干粉针剂 · No verified English nameCXSL2501029 | Qi De Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized |
| 2025/12/02New drug · Class 2.4 | 注射用甲苯磺酸瑞马唑仑 · No verified English nameCXHS2500146 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/12/02New drug · Class 1 | HRS-1780 片 · No verified English nameCXHL2501317 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/12/02New drug · Class 1 | HRS-1780 片 · No verified English nameCXHL2501316 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/12/02New drug · Class 1 | HT-101注射液 · No verified English nameCXHL2501315 | Suzhou Xing Yao Kun Ze Biopharmaceutical Co., Ltd. romanized; An Ji Xing Yao Kun Ze Biopharmaceutical Co., Ltd. romanized |
| 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 |
76 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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