YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 359 drug applications between 12 October 2023 and 18 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 101, covering 70 drug names.
2023/10/12 – 2023/10/18
- New acceptances this week
- 359
- Drugs with new generic filings (by drug name, de-duplicated)
- 70
- 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
359filings, 101 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 161 |
| Generic | 101 |
| New drug | 69 |
| Import | 16 |
| Import re-registration | 7 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 247 |
| TCM | 68 |
| Therapeutic biologic | 40 |
| Prophylactic biologic | 3 |
| 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
70 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 | Famotidine Injection | 4 | 3 | 8 |
| 3 | Lactulose Oral Solution | 3 | 2 | 34 |
| 4 | 小儿复方氨基酸注射液(19AA-I) · No verified English name | 3 | 1 | 2 |
| 5 | Ixazomib Citrate Capsules | 3 | 1 | 7 |
| 6 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 3 | 1 | 2 |
| 7 | Oseltamivir Phosphate For Oral Suspension | 3 | 1 | 2 |
| 8 | Diprophylline Injection | 2 | 2 | 7 |
| 9 | Ezetimibe Tablets | 2 | 2 | 4 |
| 10 | Lidocaine and Prilocaine Cream | 2 | 2 | 24 |
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
224 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangxi Jin Xing Pharmaceutical Co., Ltd. romanized | 10 | 9 | 0 |
| 2 | Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized | 8 | 3 | 0 |
| 3 | Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | 6 | 3 | 6 |
| 4 | Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Guangxi Hong Ji Pharma Group Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Shaanxi Nian Qing Bao Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Pfizer Europe MA EEIG | 4 | 3 | 0 |
| 8 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 4 | 3 | 4 |
| 9 | Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Wuhan Lang Lai Technology Development Co., Ltd. romanized | 4 | 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
124 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/10/18Import · Class 1 | Sisunatovir 片 · No verified English nameJXHL2300255 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2023/10/18Generic · Class 3 | 富马酸酮替芬滴眼液 · No verified English nameCYHS2302799 | Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized |
| 2023/10/18Generic · Class 3 | Aminophylline InjectionCYHS2302798 | Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/10/18Generic · Class 3 | Calcium Acetate Oral SolutionCYHS2302797 | Hebei Hua Chen Pharma Group Co., Ltd. romanized |
| 2023/10/18Generic · Class 3 | Acetylcysteine InjectionCYHS2302796 | Shaanxi Li Cai Pharma Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized |
| 2023/10/18Generic · Class 3 | Diprophylline InjectionCYHS2302795 | Xizang Hai Jin Pharma Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2023/10/18New drug · Class 1 | BD211自体CD34+造血干细胞注射液 · No verified English nameCXSL2300710 | Shanghai Ben Dao Ji Yin Technology Co., Ltd. romanized |
| 2023/10/18New drug · Class 2.2 | 赛帕利单抗注射液 · No verified English nameCXSL2300709 | Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/10/18New drug · Class 2.2 | 赛帕利单抗注射液 · No verified English nameCXSL2300708 | Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/10/18New drug · Class 1 | Domvanalimab注射液 · No verified English nameCXSL2300707 | Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/10/18New drug · Class 1 | Domvanalimab注射液 · No verified English nameCXSL2300706 | Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/10/18New drug · Class 1 | Tinlarebant 片 · No verified English nameCXHL2301124 | Bei Liang Sheng Ji Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2023/10/18New drug · Class 1 | TQB3909片 · No verified English nameCXHL2301123 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/10/18New drug · Class 1 | TQB3909片 · No verified English nameCXHL2301122 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/10/18New drug · Class 1 | TQB3702片 · No verified English nameCXHL2301121 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 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 |
94 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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