YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 404 drug applications between 11 October 2023 and 17 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 111, covering 75 drug names.
2023/10/11 – 2023/10/17
- New acceptances this week
- 404
- Drugs with new generic filings (by drug name, de-duplicated)
- 75
- 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
404filings, 111 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 181 |
| Generic | 111 |
| New drug | 79 |
| Import | 24 |
| Import re-registration | 6 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 283 |
| TCM | 64 |
| Therapeutic biologic | 51 |
| 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
75 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 | Famotidine Injection | 4 | 3 | 8 |
| 4 | Lactulose Oral Solution | 3 | 2 | 34 |
| 5 | Minoxidil Liniment | 3 | 2 | 52 |
| 6 | 小儿复方氨基酸注射液(19AA-I) · No verified English name | 3 | 1 | 2 |
| 7 | Ixazomib Citrate Capsules | 3 | 1 | 7 |
| 8 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 3 | 1 | 2 |
| 9 | Oseltamivir Phosphate For Oral Suspension | 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
237 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 | Qilu Pharmaceutical Co., Ltd. | 8 | 4 | 8 |
| 3 | Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized | 8 | 3 | 0 |
| 4 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 8 | 2 | 0 |
| 5 | Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | 6 | 3 | 6 |
| 6 | Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Pfizer Europe MA EEIG | 5 | 4 | 0 |
| 8 | Boehringer Ingelheim International GmbH | 5 | 2 | 0 |
| 9 | Guangxi Hong Ji Pharma Group Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Hainan Huluwa Pharmaceutical Group Co., Ltd. | 4 | 4 | 4 |
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
139 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/10/17Generic · Class 3 | Timolol Maleate Eye DropsCYHS2302790 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2023/10/17Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2302783 | Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized |
| 2023/10/17Generic · Class 3 | Famotidine InjectionCYHS2302780 | Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2023/10/17New drug · Class 1 | ZG005粉针剂 · No verified English nameCXSL2300705 | Name not romanized |
| 2023/10/17New drug · Class 1 | ZG005粉针剂 · No verified English nameCXSL2300704 | Name not romanized |
| 2023/10/17New drug · Class 1 | HSK21542注射液 · No verified English nameCXHS2300094 | Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2023/10/17New drug · Class 1 | YR001软膏 · No verified English nameCXHL2301120 | Hangzhou Yi Rui Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/10/17New drug · Class 1 | YR001软膏 · No verified English nameCXHL2301119 | Hangzhou Yi Rui Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/10/16Import · Class 1 | DS-7011a · No verified English nameJXSL2300185 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2023/10/16New drug · Class 1 | KAL-002 · No verified English nameCXSL2300703 | Sichuan Yan Yang Bio Technology Co., Ltd. romanized |
| 2023/10/16New drug · Class 1 | KAL-002 · No verified English nameCXSL2300702 | Sichuan Yan Yang Bio Technology Co., Ltd. romanized |
| 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 |
109 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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