YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 290 drug applications between 21 July 2023 and 27 July 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 66, covering 52 drug names.
2023/07/21 – 2023/07/27
- New acceptances this week
- 290
- Drugs with new generic filings (by drug name, de-duplicated)
- 52
- 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
290filings, 66 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 142 |
| Generic | 66 |
| New drug | 48 |
| Import | 24 |
| Unspecified | 7 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 168 |
| TCM | 62 |
| Therapeutic biologic | 54 |
| Prophylactic biologic | 5 |
| 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
52 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Pravastatin Sodium Tablets | 4 | 2 | 2 |
| 2 | Roxatidine Acetate Hydrochloride For Injection | 2 | 2 | 5 |
| 3 | Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution | 2 | 2 | 8 |
| 4 | Ethyl Iosapentate Capsules | 2 | 1 | 27 |
| 5 | Tacrolimus Sustained-release Capsules | 2 | 1 | 6 |
| 6 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 7 | Carfilzomib For Injection | 2 | 1 | 0 |
| 8 | Cefuroxime Sodium for Injection | 2 | 1 | 8 |
| 9 | 注射用头孢唑肟钠 · No verified English name | 2 | 1 | 4 |
| 10 | 米诺地尔泡沫剂 · 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
165 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Sichuan He Li Xin Jian Pharma Co., Ltd. romanized | 28 | 27 | 0 |
| 2 | Guizhou Tian Di Pharma Co., Ltd. romanized | 12 | 3 | 0 |
| 3 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 5 | 4 | 3 |
| 4 | Takeda Development Center Americas Inc. | 5 | 2 | 0 |
| 5 | Sanofi Winthrop Industrie | 5 | 1 | 0 |
| 6 | Changsha Xin Lin Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Shaanxi Feng Wu Chen Da Yao Tang Pharmaceutical Factory Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized | 4 | 3 | 0 |
| 9 | Janssen Research & Development LLC | 4 | 2 | 0 |
| 10 | Bristol-Myers Squibb Company | 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
91 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/07/27Import · Class 1 | Talquetamab注射液 · No verified English nameJXSL2300141 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/07/27Import · Class 1 | Talquetamab注射液 · No verified English nameJXSL2300140 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/07/27Generic · Class 3 | Ursodeoxycholic acid oral suspensionCYHS2302006 | Name not romanized; Jiangsu Yun Yang Group Pharma Co., Ltd. romanized |
| 2023/07/27New drug · Class 1 | 皮肤试验用结核分枝杆菌抗原(EM) · No verified English nameCXSL2300522 | An Bo Zhi Lian (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/07/27New drug · Class 1 | 皮肤试验用结核分枝杆菌抗原(EM) · No verified English nameCXSL2300521 | An Bo Zhi Lian (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/07/27New drug · Class 1 | 皮肤试验用结核分枝杆菌抗原(EM) · No verified English nameCXSL2300520 | An Bo Zhi Lian (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/07/27New drug · Class 1 | 皮肤试验用结核分枝杆菌抗原(EM) · No verified English nameCXSL2300519 | An Bo Zhi Lian (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/07/27New drug · Class 3.3 | 重组带状疱疹疫苗（CHO细胞） · No verified English nameCXSL2300518 | Jiangsu Rui Ke Bio Technology Co., Ltd. romanized; Beijing An Bai Sheng Bio Technology Co., Ltd. romanized |
| 2023/07/27New drug · Class 1 | IMM47注射液 · No verified English nameCXSL2300517 | Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/07/27New drug · Class 1 | KD6005注射液 · No verified English nameCXSL2300516 | Shanghai Kang Dai Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Sai Jin Biopharmaceuticals Co., Ltd. romanized |
| 2023/07/26Import · Class 1 | Aficamten片 · No verified English nameJXHL2300177 | Cytokinetics Incorporated; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd |
| 2023/07/26Import · Class 1 | MK-5684片 · No verified English nameJXHL2300176 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2023/07/26Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2302005 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2023/07/26Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2302004 | Guangdong Ke Hong Pharma Co., Ltd. romanized |
| 2023/07/26Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2302003 | Guangdong Ke Hong Pharma Co., Ltd. romanized |
| 2023/07/26Generic · Class 3 | Polaprezinc GranulesCYHS2301999 | Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized |
| 2023/07/26Generic · Class 3 | 盐酸肾上腺素注射液 · No verified English nameCYHS2301996 | Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/07/26Generic · Class 3 | 米诺地尔泡沫剂（男用） · No verified English nameCYHS2301995 | Shanxi Zhen Dong An Xin Biopharmaceutical Co., Ltd. romanized |
| 2023/07/26Generic · Class 3 | 米诺地尔泡沫剂（女用） · No verified English nameCYHS2301994 | Shanxi Zhen Dong An Xin Biopharmaceutical Co., Ltd. romanized |
| 2023/07/26New drug · Class 3.3 | 四价流感病毒裂解疫苗 · No verified English nameCXSS2300060 | Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized |
| 2023/07/26New drug · Class 3.3 | 四价流感病毒裂解疫苗 · No verified English nameCXSS2300059 | Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized |
| 2023/07/26New drug · Class 3.3 | 贝伐珠单抗注射液 · No verified English nameCXSS2300058 | Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2023/07/26New drug · Class 3.3 | 德谷胰岛素利拉鲁肽注射液 · No verified English nameCXSL2300515 | Hui Sheng Biopharmaceutical Co., Ltd. romanized |
| 2023/07/26New drug · Class 1 | 多抗原自体免疫细胞注射液 · No verified English nameCXSL2300514 | Heng Rui Yuan Zheng (Shanghai) Bio Technology Co., Ltd. romanized; Heng Rui Yuan Zheng (Shenzhen) Bio Technology Co., Ltd. romanized |
| 2023/07/26New drug · Class 1 | TQA3038 注射液 · No verified English nameCXHL2300820 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/07/26New drug · Class 1 | APG-2575片 · No verified English nameCXHL2300819 | Suzhou Ya Sheng Pharma Co., Ltd. romanized |
| 2023/07/26New drug · Class 1 | APG-2575片 · No verified English nameCXHL2300818 | Suzhou Ya Sheng Pharma Co., Ltd. romanized |
| 2023/07/26New drug · Class 1 | APG-2575片 · No verified English nameCXHL2300817 | Suzhou Ya Sheng Pharma Co., Ltd. romanized |
| 2023/07/25Import · Class 3.1 | 注射用培图罗凝血素α · No verified English nameJXSS2300063 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2023/07/25Import · Class 3.1 | 注射用培图罗凝血素α · No verified English nameJXSS2300062 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
61 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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