YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 553 drug applications between 9 October 2023 and 15 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 145, covering 100 drug names.
2023/10/09 – 2023/10/15
- New acceptances this week
- 553
- Drugs with new generic filings (by drug name, de-duplicated)
- 100
- 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
553filings, 145 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 250 |
| Generic | 145 |
| New drug | 109 |
| Import | 27 |
| Import re-registration | 12 |
| Unspecified | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 406 |
| TCM | 70 |
| Therapeutic biologic | 69 |
| Prophylactic biologic | 7 |
| 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
100 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Diquafosol Sodium Eye Drops | 6 | 5 | 5 |
| 2 | Edoxaban Tosilate Tablets | 6 | 2 | 9 |
| 3 | Minoxidil Liniment | 5 | 3 | 52 |
| 4 | Lactulose Oral Solution | 4 | 3 | 34 |
| 5 | Oseltamivir Phosphate For Oral Suspension | 4 | 2 | 2 |
| 6 | Famotidine Injection | 3 | 2 | 8 |
| 7 | Nicorandil for Injection | 3 | 2 | 1 |
| 8 | 小儿复方氨基酸注射液(19AA-I) · No verified English name | 3 | 1 | 2 |
| 9 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 3 | 1 | 2 |
| 10 | Ezetimibe Tablets | 2 | 2 | 4 |
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
311 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangxi Jin Xing Pharmaceutical Co., Ltd. romanized | 19 | 18 | 0 |
| 2 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 13 | 4 | 0 |
| 3 | Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized | 8 | 3 | 0 |
| 4 | Sichuan Sen Ke Pharmaceutical Co., Ltd. romanized | 6 | 5 | 0 |
| 5 | Sichuan Kelun Pharmaceutical Co., Ltd. | 6 | 3 | 2 |
| 6 | Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | 6 | 3 | 6 |
| 7 | Jiangsu En Hua Pharma Co., Ltd. romanized | 6 | 2 | 0 |
| 8 | Beijing Foyou Pharma CO.,LTD | 5 | 4 | 3 |
| 9 | Qilu Pharmaceutical Co., Ltd. | 5 | 3 | 5 |
| 10 | Boehringer Ingelheim International GmbH | 5 | 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
191 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/10/14Import · Class 1 | Tarlatamab · No verified English nameJXSL2300184 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2023/10/14Import · Class 1 | Tarlatamab · No verified English nameJXSL2300183 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2023/10/14Import · Class 1 | Tarlatamab · No verified English nameJXSL2300182 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2023/10/14Generic · Class 3 | 氟[18F]化钠注射液 · No verified English nameCYHS2302776 | Nanjing Jiang Yuan An Di Ke Zheng Dian Zi Research Development Co., Ltd. romanized |
| 2023/10/14Generic · Class 3 | Lanthanum Carbonate Hydrate GranulesCYHS2302774 | Hunan Ming Rui Pharmaceutical Co., Ltd. romanized |
| 2023/10/14Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2302769 | Sui Cheng Pharma Co., Ltd. romanized; Zhengzhou Zhi He Pharma Co., Ltd. romanized |
| 2023/10/14Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2302768 | Sui Cheng Pharma Co., Ltd. romanized; Zhengzhou Zhi He Pharma Co., Ltd. romanized |
| 2023/10/14Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2302767 | Sui Cheng Pharma Co., Ltd. romanized; Zhengzhou Zhi He Pharma Co., Ltd. romanized |
| 2023/10/14Generic · Class 3 | Timolol Maleate Eye DropsCYHS2302766 | Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2023/10/14Generic · Class 3 | 小儿复方氨基酸注射液(19AA-I) · No verified English nameCYHS2302763 | Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2023/10/14Generic · Class 3 | 小儿复方氨基酸注射液(19AA-I) · No verified English nameCYHS2302762 | Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2023/10/14Generic · Class 3 | 小儿复方氨基酸注射液(19AA-I) · No verified English nameCYHS2302761 | Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2023/10/14Generic · Class 3 | Minoxidil LinimentCYHS2302758 | Guangdong Yi Kang Na Si Biopharmaceuticals Technology Co., Ltd. romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2023/10/14Generic · Class 3 | Minoxidil LinimentCYHS2302757 | Guangdong Yi Kang Na Si Biopharmaceuticals Technology Co., Ltd. romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2023/10/14New drug · Class 2.1 | 万通筋骨巴布膏 · No verified English nameCXZS2300021 | Tong Hua Wan Tong Pharma Co., Ltd. romanized |
| 2023/10/14New drug · Class 1 | 注射用ZHB114 · No verified English nameCXSL2300701 | Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized; Changzhou Qian Hong Sheng Hua Pharmaceutical Co., Ltd. romanized |
| 2023/10/14New drug · Class 1 | IBI343 · No verified English nameCXSL2300700 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2023/10/14New drug · Class 1 | KL003细胞注射液 · No verified English nameCXSL2300699 | Kang Lin Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2023/10/14New drug · Class 1 | ZX2010注射液 · No verified English nameCXSL2300698 | Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized |
| 2023/10/14New drug · Class 1 | SC0011片 · No verified English nameCXHL2301118 | Wuxi Ling Fang Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/10/14New drug · Class 2.2 | LPC-013口溶膜 · No verified English nameCXHL2301117 | Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized |
| 2023/10/14New drug · Class 2.2 | LPC-013口溶膜 · No verified English nameCXHL2301116 | Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized |
| 2023/10/14New drug · Class 1 | BT-114143注射液 · No verified English nameCXHL2301115 | Sai Nuo Ha Bo Pharma (Chengdu) Co., Ltd. romanized |
| 2023/10/14New drug · Class 1 | TNP-2092软膏 · No verified English nameCXHL2301114 | Dan Nuo Pharmaceuticals (Zhong Shan) Co., Ltd. romanized |
| 2023/10/14New drug · Class 1 | BT-114143注射液 · No verified English nameCXHL2301113 | Sai Nuo Ha Bo Pharma (Chengdu) Co., Ltd. romanized |
| 2023/10/14New drug · Class 1 | DA818胶囊 · No verified English nameCXHL2301112 | Chengdu Di Ao Jiu Hong Pharmaceutical Factory romanized |
| 2023/10/14New drug · Class 1 | DA818胶囊 · No verified English nameCXHL2301111 | Chengdu Di Ao Jiu Hong Pharmaceutical Factory romanized |
| 2023/10/13Import · Class 2.2 | 注射用罗特西普 · No verified English nameJXSL2300181 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2023/10/13Import · Class 2.2 | 注射用罗特西普 · No verified English nameJXSL2300180 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2023/10/13Import · Class 3.1 | 重组B群脑膜炎球菌多组分吸附疫苗 · No verified English nameJXSL2300179 | GSK Vaccines S.r.l. |
161 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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