YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 307 drug applications between 5 June 2025 and 11 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 95, covering 64 drug names.
2025/06/05 – 2025/06/11
- New acceptances this week
- 307
- Drugs with new generic filings (by drug name, de-duplicated)
- 64
- Accepted this week, now under review
- 50
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
307filings, 95 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 125 |
| Generic | 95 |
| New drug | 60 |
| Import | 17 |
| Unspecified | 7 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 205 |
| TCM | 48 |
| Therapeutic biologic | 48 |
| 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
64 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Acetylcysteine Injection | 11 | 10 | 53 |
| 2 | Sodium Nitroprusside Injection | 3 | 2 | 15 |
| 3 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 4 | Paliperidone Palmitate Injection | 3 | 1 | 8 |
| 5 | Ethyl Iosapentate Capsules | 2 | 2 | 27 |
| 6 | Bilastine Oral Solution | 2 | 2 | 8 |
| 7 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 8 | Folic acid injection | 2 | 1 | 1 |
| 9 | Zoledronic Acid Injection | 2 | 1 | 2 |
| 10 | 多种微量元素注射液(Ⅲ) · 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
220 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Qilu Pharmaceutical Co., Ltd. | 5 | 4 | 1 |
| 2 | Xian Da Heng Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 3 | Shandong Qidu Pharmaceutical Co., Ltd. | 4 | 3 | 3 |
| 4 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 5 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 4 | 2 | 0 |
| 6 | Eli Lilly Nederland B.V. | 4 | 1 | 0 |
| 7 | Guizhou De Chang Xiang Pharmaceuticals Co., Ltd. romanized | 3 | 3 | 0 |
| 8 | Zun Yi Hua Wei Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 9 | Merck Sharp & Dohme B.V. | 3 | 2 | 0 |
| 10 | Novartis Pharma AG | 3 | 2 | 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 |
|---|---|---|
| 2025/06/11Import · Class 3.1 | Dostarlimab注射液 · No verified English nameJXSL2500087 | GlaxoSmithKline (Ireland) Limited; GlaxoSmithKline (China) Investment Company Limited |
| 2025/06/11Import · Class 1 | 注射用MK-1022 · No verified English nameJXSL2500086 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2025/06/11Import · Class 1 | BI 690517片 · No verified English nameJXHL2500132 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2025/06/11Generic · Class 3 | Timolol Maleate Eye DropsCYHS2502062 | Guangdong Nan Guo Pharma Co., Ltd. romanized |
| 2025/06/11Generic · Class 3 | Bilastine Oral SolutionCYHS2502060 | Nanjing Huang Long Bio Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized |
| 2025/06/11Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G4.25%) · No verified English nameCYHS2502055 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized |
| 2025/06/11Generic · Class 3 | 中性腹膜透析液(碳酸氢盐-G4.25%) · No verified English nameCYHS2502052 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized |
| 2025/06/11New drug · Class 3.4 | 甘精胰岛素利司那肽注射液(Ⅱ) · No verified English nameCXSS2500063 | Sai Nuo Fei (Beijing) Pharmaceutical Co., Ltd. romanized |
| 2025/06/11New drug · Class 3.4 | 甘精胰岛素利司那肽注射液(Ⅰ) · No verified English nameCXSS2500062 | Sai Nuo Fei (Beijing) Pharmaceutical Co., Ltd. romanized |
| 2025/06/11New drug · Class 1 | CM536注射液 · No verified English nameCXSL2500474 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2025/06/11New drug · Class 2.2 | SPIEC肠溶微片 · No verified English nameCXHL2500551 | Jilin Tian Heng Pharma Co., Ltd. romanized |
| 2025/06/10Import · Class 1 | Muvalaplin片 · No verified English nameJXHL2500131 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/06/10Generic · Class 3 | 头孢羟氨苄干混悬剂 · No verified English nameCYHS2502047 | Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Sichuan Sai Zhuo Pharma Co., Ltd. romanized |
| 2025/06/10Generic · Class 3 | 头孢羟氨苄干混悬剂 · No verified English nameCYHS2502046 | Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Sichuan Sai Zhuo Pharma Co., Ltd. romanized |
| 2025/06/10Generic · Class 3 | Acetylcysteine InjectionCYHS2502043 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized |
| 2025/06/10Generic · Class 3 | Acetylcysteine InjectionCYHS2502042 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized |
| 2025/06/10Generic · Class 3 | 布洛芬去氧肾上腺素片 · No verified English nameCYHS2502033 | Kang Zhi Pharma Co., Ltd. romanized |
| 2025/06/10Generic · Class 3 | Loxoprofen Sodium Oral SolutionCYHS2502032 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2025/06/10Generic · Class 3 | Ciclosporin Eye Drops(Ⅱ)CYHL2500108 | Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized |
| 2025/06/10New drug · Class 2.3 | 金振口服液 · No verified English nameCXZL2500038 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2025/06/10New drug · Class 3.3 | 阿达木单抗注射液 · No verified English nameCXSS2500061 | Sichuan Lu Zhou Bu Zhang Biopharmaceutical Co., Ltd. romanized; Beijing Zhao Yan Bio Technology Co., Ltd. romanized |
| 2025/06/10New drug · Class 1 | GR1802注射液 · No verified English nameCXSL2500470 | Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized |
| 2025/06/10New drug · Class 1 | GR1802注射液 · No verified English nameCXSL2500469 | Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized |
| 2025/06/10New drug · Class 1.2 | NT-INF-001制剂 · No verified English nameCXSL2500468 | Jia Yi Biopharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2025/06/10New drug · Class 2.2 | QL2107注射液 · No verified English nameCXSL2500467 | Qilu Pharmaceutical Co., Ltd. |
| 2025/06/10New drug · Class 1 | 注射用QLS31905 · No verified English nameCXSL2500466 | Qilu Pharmaceutical Co., Ltd. |
| 2025/06/10New drug · Class 1 | HRS-6093片 · No verified English nameCXHL2500550 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/06/10New drug · Class 1 | HRS-6093片 · No verified English nameCXHL2500549 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/06/10New drug · Class 1 | QLH12016胶囊 · No verified English nameCXHL2500548 | Qilu Pharmaceutical Co., Ltd. |
| 2025/06/10New drug · Class 1 | QLH12016胶囊 · No verified English nameCXHL2500547 | Qilu Pharmaceutical Co., Ltd. |
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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