YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 309 drug applications between 21 August 2024 and 27 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 85, covering 62 drug names.
2024/08/21 – 2024/08/27
- New acceptances this week
- 309
- Drugs with new generic filings (by drug name, de-duplicated)
- 62
- Accepted this week, now under review
- 1
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
309filings, 85 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 138 |
| Generic | 85 |
| New drug | 40 |
| Unspecified | 22 |
| Import | 13 |
| Import re-registration | 11 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 188 |
| TCM | 70 |
| Therapeutic biologic | 36 |
| Biologic | 11 |
| Prophylactic biologic | 4 |
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
62 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Nicardipine Hydrochloride Injection | 5 | 3 | 13 |
| 2 | Lactulose Oral Solution | 4 | 2 | 34 |
| 3 | Ambroxol Hydrochloride Oral Solution | 3 | 2 | 46 |
| 4 | Riociguat Tablets | 3 | 1 | 4 |
| 5 | Vonoprazan Fumarate Tablets | 2 | 2 | 60 |
| 6 | Dapoxetine Hydrochloride Tablets | 2 | 2 | 20 |
| 7 | Sodium Picosulfate Oral Solution | 2 | 1 | 0 |
| 8 | Brexpiprazole Tablets | 2 | 1 | 31 |
| 9 | Bumetanide Injection | 2 | 1 | 13 |
| 10 | Empagliflozin Tablets | 2 | 1 | 18 |
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
194 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novo Nordisk A/S | 10 | 1 | 0 |
| 2 | Janssen Research & Development LLC | 7 | 2 | 0 |
| 3 | Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 4 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 5 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 4 | 4 | 0 |
| 6 | Zhong Jing Wan Xi Pharmaceutical Co., Ltd. romanized | 4 | 3 | 0 |
| 7 | Anhui Pioneer Pharmaceutical Co., Ltd | 4 | 3 | 4 |
| 8 | Henan He Zhi Pharmaceuticals Technology Co., Ltd. romanized | 4 | 2 | 4 |
| 9 | Hubei Mei Lin Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Novo Nordisk Pharma AG | 4 | 1 | 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
83 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/08/27Generic · Class 3 | Bromhexine Hydrochloride InjectionCYHS2402789 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized |
| 2024/08/27Generic · Class 3 | Azilsartan and Amlodipine TabletsCYHS2402787 | Shanghai Hui Lun Pharmaceuticals Co., Ltd. romanized; Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized |
| 2024/08/27Generic · Class 3 | Bumetanide InjectionCYHS2402785 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2024/08/27Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2402784 | Chengdu Hua Yu Pharmaceutical Co., Ltd. romanized |
| 2024/08/27Generic · Class 3 | Bumetanide InjectionCYHS2402783 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2024/08/27Generic · Class 3 | Salbutamol Sulfate injectionCYHS2402782 | Henan Pu Rui Pharma Co., Ltd. romanized |
| 2024/08/27Generic · Class 3 | Metronidazole TabletsCYHS2402779 | Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized |
| 2024/08/27Generic · Class 3 | 利多卡因丙胺卡因气雾剂 · No verified English nameCYHL2400176 | Jiangsu Lianhuan Pharmaceutical Co.,Ltd. |
| 2024/08/27New drug · Class 3.1 | 桃核承气颗粒 · No verified English nameCXZS2400028 | Guangdong Yi Fang Pharmaceutical Co., Ltd. romanized |
| 2024/08/27New drug · Class 1 | ZT006片 · No verified English nameCXSL2400569 | Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/08/27New drug · Class 1 | ZT006片 · No verified English nameCXSL2400568 | Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/08/27New drug · Class 1 | ZT006片 · No verified English nameCXSL2400567 | Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/08/27New drug · Class 1 | ZT006片 · No verified English nameCXSL2400566 | Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/08/27New drug · Class 1 | ZT006片 · No verified English nameCXSL2400565 | Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/08/27New drug · Class 1 | ZT006片 · No verified English nameCXSL2400564 | Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/08/27New drug · Class 2.4 | 注射用艾博韦泰 · No verified English nameCXHL2400865 | Qian Yan Bio Pharma (Nanjing) Co., Ltd. romanized |
| 2024/08/27New drug · Class 1 | 注射用AC02 · No verified English nameCXHL2400864 | Nanjing Han Xin Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/08/26Import · Class 2.2 | 司美格鲁肽注射液 · No verified English nameJXSS2400069 | Novo Nordisk Pharma AG; Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd. |
| 2024/08/26Import · Class 2.2 | 司美格鲁肽注射液 · No verified English nameJXSS2400068 | Novo Nordisk Pharma AG; Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd. |
| 2024/08/26Import · Class 2.1 | Amivantamab注射液(皮下注射) · No verified English nameJXSL2400156 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/08/26Import · Class 2.1 | Amivantamab注射液(皮下注射) · No verified English nameJXSL2400155 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/08/26Import · Class 2.4 | Lazertinib片 · No verified English nameJXHL2400207 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/08/26New drug · Class 2.2 | 九价人乳头瘤病毒疫苗(大肠埃希菌) · No verified English nameCXSS2400089 | Xiamen Wan Tai Cang Hai Bio Technology Co., Ltd. romanized |
| 2024/08/26New drug · Class 2.2 | 九价人乳头瘤病毒疫苗(大肠埃希菌) · No verified English nameCXSS2400088 | Xiamen Wan Tai Cang Hai Bio Technology Co., Ltd. romanized |
| 2024/08/26New drug · Class 1 | CA1001注射液 · No verified English nameCXSL2400563 | Xi Xi Ou Ai (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2024/08/24Import · Class 1 | Nivolumab/Relatlimab固定剂量复方注射液 · No verified English nameJXSL2400154 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2024/08/24Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2402775 | Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized; Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized |
| 2024/08/24New drug · Class 1 | KYS202003A注射液 · No verified English nameCXSL2400562 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2024/08/24New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2400561 | Beijing Bei Lai Pharma Co., Ltd. romanized |
| 2024/08/24New drug · Class 2.4 | 苯环喹溴铵鼻喷雾剂 · No verified English nameCXHS2400083 | Yin Gu Pharmaceutical Co., Ltd. romanized |
53 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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