YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 337 drug applications between 24 October 2023 and 30 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 90, covering 70 drug names.
2023/10/24 – 2023/10/30
- New acceptances this week
- 337
- Drugs with new generic filings (by drug name, de-duplicated)
- 70
- 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
337filings, 90 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 170 |
| Generic | 90 |
| New drug | 56 |
| Unspecified | 11 |
| Import | 5 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 236 |
| TCM | 57 |
| Therapeutic biologic | 34 |
| Biologic | 7 |
| Prophylactic biologic | 3 |
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
70 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Acetylcysteine Oral Solution | 3 | 1 | 11 |
| 2 | Piracetam Injection | 3 | 1 | 9 |
| 3 | Nicardipine Hydrochloride Injection | 3 | 1 | 13 |
| 4 | Sodium Valproate Sustained-release Tablets(I) | 2 | 2 | 4 |
| 5 | Betamethasone Sodium Phosphate Injection | 2 | 1 | 5 |
| 6 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 7 | Metformin Hydrochloride And Empagliflozin Extended Release Tablets | 2 | 1 | 12 |
| 8 | Tolvaptan Orally Disintegrating Tablets | 2 | 1 | 5 |
| 9 | Torsemide Injection | 2 | 1 | 1 |
| 10 | Lacosamide Tablets | 2 | 1 | 0 |
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
189 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanxi Shuang Yan Pharma Co., Ltd. romanized | 28 | 9 | 0 |
| 2 | Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized | 18 | 17 | 0 |
| 3 | Hebei Yu Zhi Lin Pharma Co., Ltd. romanized | 8 | 8 | 0 |
| 4 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 8 | 4 | 4 |
| 5 | Jin He Zang Yao Co., Ltd. romanized | 7 | 6 | 0 |
| 6 | Haerbin Han Bang Medical Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Wuhan Bin Hu Shuang He Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 8 | Li Bang Pharma (Shanghai) Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Takeda Manufacturing Austria AG | 4 | 1 | 0 |
| 10 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized | 3 | 3 | 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
96 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/10/30New drug · Class 1 | TQB2928注射液 · No verified English nameCXSL2300742 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/10/30New drug · Class 1 | 注射用MK-2870 · No verified English nameCXSL2300741 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2023/10/30New drug · Class 1 | BT02单克隆抗体注射液 · No verified English nameCXSL2300740 | Shanghai Bai Quan Bio Technology Co., Ltd. romanized |
| 2023/10/30New drug · Class 2.2 | HZ023口溶膜 · No verified English nameCXHL2301183 | Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/10/28Generic · Class 3 | Piracetam InjectionCYHS2302936 | Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized |
| 2023/10/28Generic · Class 3 | Piracetam InjectionCYHS2302935 | Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized |
| 2023/10/28Generic · Class 3 | Piracetam InjectionCYHS2302934 | Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized |
| 2023/10/28Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2302933 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/10/28Generic · Class 3 | Peramivir InjectionCYHS2302932 | Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized; Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2023/10/28Generic · Class 3 | Landiolol Hydrochloride for InjectionCYHS2302929 | Shanghai Bao Long Bio Technology Co., Ltd. romanized; Tianjin Jin Yao Pharma Co., Ltd. romanized |
| 2023/10/28Generic · Class 3 | Betamethasone Sodium Phosphate InjectionCYHS2302928 | Jiangsu Shen Long Pharma Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized |
| 2023/10/28Generic · Class 3 | Betamethasone Sodium Phosphate InjectionCYHS2302927 | Jiangsu Shen Long Pharma Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized |
| 2023/10/28New drug · Class 1 | TJ033721注射液 · No verified English nameCXSL2300739 | Tian Jing Bio Technology (Shanghai) Co., Ltd. romanized |
| 2023/10/28New drug · Class 1 | ZT002注射液 · No verified English nameCXSL2300738 | Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/10/28New drug · Class 1 | AK112注射液 · No verified English nameCXSL2300737 | Kang Fang Sai Nuo Pharmaceuticals Co., Ltd. romanized |
| 2023/10/28New drug · Class 1 | AK130注射液 · No verified English nameCXSL2300736 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2023/10/28New drug · Class 1 | 注射用BGB-A3055 · No verified English nameCXSL2300735 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2023/10/28New drug · Class 1 | 注射用GRK-006 · No verified English nameCXHL2301182 | Hui An Kai (Xiamen) Pharmaceuticals Technology Co., Ltd. romanized; Suzhou Ge Lan Ke Pharmaceuticals Technology Co., Ltd. romanized; Quan Zhou Hai Chuang Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/10/28New drug · Class 1 | TQG3020片 · No verified English nameCXHL2301181 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/10/28New drug · Class 1 | TQG3020片 · No verified English nameCXHL2301180 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/10/28New drug · Class 1 | TQG3020片 · No verified English nameCXHL2301179 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/10/28New drug · Class 1 | TQG3020片 · No verified English nameCXHL2301178 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/10/28New drug · Class 1 | SIM0501片 · No verified English nameCXHL2301177 | Shanghai Xian Xiang Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/10/28New drug · Class 1 | SIM0501片 · No verified English nameCXHL2301176 | Shanghai Xian Xiang Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/10/28New drug · Class 1 | TQH3906胶囊 · No verified English nameCXHL2301175 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/10/28New drug · Class 1 | TQH3906胶囊 · No verified English nameCXHL2301174 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/10/27Import · Class 1 | DS-6000a · No verified English nameJXSL2300189 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2023/10/27Generic · Class 3 | 盐酸拉贝洛尔氯化钠注射液 · No verified English nameCYHS2302925 | Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2023/10/27Generic · Class 3 | Milrinone InjectionCYHS2302916 | Hubei Heng Di Pharma Co., Ltd. romanized; Hubei Jin Yao Pharma Co., Ltd. romanized |
| 2023/10/27Generic · Class 3 | Milrinone InjectionCYHS2302915 | Hubei Heng Di Pharma Co., Ltd. romanized; Hubei Jin Yao Pharma Co., Ltd. romanized |
66 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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