YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 355 drug applications between 2 November 2023 and 8 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 92, covering 64 drug names.
2023/11/02 – 2023/11/08
- New acceptances this week
- 355
- Drugs with new generic filings (by drug name, de-duplicated)
- 64
- Accepted this week, now under review
- 0
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
355filings, 92 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 169 |
| Generic | 92 |
| New drug | 65 |
| Import re-registration | 15 |
| Import | 10 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 226 |
| TCM | 86 |
| Therapeutic biologic | 41 |
| Biologic | 1 |
| 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
64 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 2 | Norepinephrine Bitartrate Injection | 4 | 2 | 9 |
| 3 | Benidipine Hydrochloride Tablets | 3 | 2 | 4 |
| 4 | Minoxidil Liniment | 3 | 2 | 52 |
| 5 | 中/长链脂肪乳注射液(C6~24) · No verified English name | 3 | 1 | 0 |
| 6 | Piracetam Injection | 3 | 1 | 9 |
| 7 | Potassium Phosphates Injection | 2 | 2 | 2 |
| 8 | 氧 · No verified English name | 2 | 2 | 15 |
| 9 | Potassium Chloride Injection | 2 | 2 | 10 |
| 10 | Famotidine Injection | 2 | 2 | 8 |
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
206 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized | 19 | 19 | 0 |
| 2 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 10 | 3 | 0 |
| 3 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 7 | 5 | 7 |
| 4 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 7 | 2 | 1 |
| 5 | Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized | 6 | 4 | 0 |
| 6 | Sanofi Winthrop Industrie | 6 | 2 | 0 |
| 7 | Guangdong Tuan Li Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Merck Sharp & Dohme B.V. | 5 | 1 | 0 |
| 9 | Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Guangxi Hong Ji Pharma Group Co., Ltd. romanized | 4 | 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
114 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/11/08Import · Class 3.1 | 帕博利珠单抗注射液 · No verified English nameJXSS2300083 | Merck Sharp & Dohme LLC; MSD Ireland(Carlow); MSD R&D (China) Co. Ltd. |
| 2023/11/08Import · Class 1 | Lebrikizumab注射液 · No verified English nameJXSL2300191 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/11/08Import · Class 1 | BAY 2433334片 · No verified English nameJXHL2300276 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2023/11/08Generic · Class 3 | Bumetanide InjectionCYHS2303056 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2023/11/08Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2303054 | Hong Yue Technology (Hu Zhou) Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized |
| 2023/11/08Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2303053 | Hainan Huluwa Pharmaceutical Group Co., Ltd. |
| 2023/11/08Generic · Class 3 | Piracetam InjectionCYHS2303050 | Shandong Hua Yao Pharmaceuticals Technology Co., Ltd. romanized; Xian Yuan Da De Tian Pharma Co., Ltd. romanized |
| 2023/11/08Generic · Class 3 | Piracetam InjectionCYHS2303049 | Shandong Hua Yao Pharmaceuticals Technology Co., Ltd. romanized; Xian Yuan Da De Tian Pharma Co., Ltd. romanized |
| 2023/11/08Generic · Class 3 | Piracetam InjectionCYHS2303048 | Shandong Hua Yao Pharmaceuticals Technology Co., Ltd. romanized; Xian Yuan Da De Tian Pharma Co., Ltd. romanized |
| 2023/11/08Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2303046 | Zhong Run Pharma Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2023/11/08Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2303045 | Zhong Run Pharma Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2023/11/08Generic · Class 3 | Famotidine InjectionCYHS2303043 | Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu Shen Long Pharma Co., Ltd. romanized |
| 2023/11/08Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2303041 | Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanized; Hunan Wu Zhou Tong Pharma Co., Ltd. romanized |
| 2023/11/08Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2303040 | Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanized; Hunan Wu Zhou Tong Pharma Co., Ltd. romanized |
| 2023/11/08New drug · Class 1 | 注射用RC88 · No verified English nameCXSL2300768 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2023/11/08New drug · Class 2.2 | CG2001 · No verified English nameCXHL2301246 | Beijing Chen Guang Pharmaceuticals Technology Co., Ltd. romanized; Chen Guang (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2023/11/08New drug · Class 2.2 | 碳[13C]美沙西汀肝脏储备功能诊断药盒 · No verified English nameCXHL2301245 | Beijing Hua Gen An Bang Technology Co., Ltd. romanized |
| 2023/11/08New drug · Class 1 | HS-10509片 · No verified English nameCXHL2301244 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/08New drug · Class 1 | HS-10509片 · No verified English nameCXHL2301243 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/08New drug · Class 1 | HS-10509片 · No verified English nameCXHL2301242 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/08New drug · Class 1 | HS-10501片 · No verified English nameCXHL2301241 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/08New drug · Class 1 | HS-10501片 · No verified English nameCXHL2301240 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/08New drug · Class 1 | HS-10501片 · No verified English nameCXHL2301239 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/08New drug · Class 1 | HS-10501片 · No verified English nameCXHL2301238 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/08New drug · Class 1 | HS-10501片 · No verified English nameCXHL2301237 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2023/11/08New drug · Class 1 | HS-10501片 · No verified English nameCXHL2301236 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/08New drug · Class 1 | SYN045片 · No verified English nameCXHL2301235 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2023/11/08New drug · Class 1 | SYN045片 · No verified English nameCXHL2301234 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2023/11/08New drug · Class 1 | SYN045片 · No verified English nameCXHL2301233 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2023/11/08New drug · Class 1 | SYN045片 · No verified English nameCXHL2301232 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
84 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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