YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 355 drug applications between 15 September 2023 and 21 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 72, covering 59 drug names.
2023/09/15 – 2023/09/21
- New acceptances this week
- 355
- Drugs with new generic filings (by drug name, de-duplicated)
- 59
- Accepted this week, now under review
- 4
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
355filings, 72 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 203 |
| Generic | 72 |
| New drug | 45 |
| Import | 20 |
| Import re-registration | 9 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 244 |
| TCM | 72 |
| Therapeutic biologic | 34 |
| Prophylactic biologic | 5 |
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
59 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sodium Valproate Sustained-release Tablets(I) | 2 | 2 | 4 |
| 2 | Diprophylline Injection | 2 | 2 | 7 |
| 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 2 | 2 | 23 |
| 4 | Tacrolimus Ointment | 2 | 1 | 6 |
| 5 | Celecoxib Tablets | 2 | 1 | 3 |
| 6 | Oxcarbazepine Tablets | 2 | 1 | 4 |
| 7 | Omeprazole and Sodium Bicarbonate Capsules | 2 | 1 | 0 |
| 8 | Sacubitril Valsartan Sodium Tablets | 2 | 1 | 70 |
| 9 | Famotidine Injection | 2 | 1 | 8 |
| 10 | 生理氯化钠溶液 · No verified English name | 2 | 1 | 17 |
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
203 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Henan Yue Ren Pharma Co., Ltd. romanized | 12 | 12 | 0 |
| 2 | Henan Shuang He Hua Li Pharma Co., Ltd. romanized | 12 | 3 | 0 |
| 3 | Boehringer Ingelheim International GmbH | 7 | 1 | 0 |
| 4 | Bard Pharmaceuticals Limited | 6 | 6 | 0 |
| 5 | AstraZeneca AB | 6 | 4 | 0 |
| 6 | Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 5 | 2 | 0 |
| 8 | Shaanxi Li Cai Pharma Co., Ltd. romanized | 5 | 2 | 2 |
| 9 | Shanghai Pharmaceuticals Group Qingdao Guo Feng Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Guangxi Shi Wan Shan Pharmaceutical Co., Ltd. romanized | 4 | 4 | 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
89 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/09/21Import · Class 2.4 | Osimertinib Mesylate TabletsJXHS2300087 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/09/21Import · Class 2.4 | Osimertinib Mesylate TabletsJXHS2300086 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/09/21Generic · Class 3 | 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2302553 | Beijing Hai Bu Pharmaceuticals Technology Co., Ltd. romanized; Tian Da Pharma (Zhuhai) Co., Ltd. romanized |
| 2023/09/21Generic · Class 3 | Methocarbamol InjectionCYHS2302547 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. |
| 2023/09/21Generic · Class 3 | Epalrestat TabletsCYHS2302544 | Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2023/09/21Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2302543 | Shandong Ke Lun Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2023/09/21Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2302542 | Shandong Ke Lun Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2023/09/21Generic · Class 3 | 阿瑞匹坦注射液 · No verified English nameCYHL2300122 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2023/09/21New drug · Class 1.1 | 比那甫西颗粒 · No verified English nameCXZS2300019 | Xinjiang Yin Duo Lan Pharma Co., Ltd. romanized |
| 2023/09/21New drug · Class 1 | 注射用AP026 · No verified English nameCXSL2300640 | An Yuan Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/09/21New drug · Class 2.4 | 注射用重组人凝血因子Ⅷ-Fc融合蛋白 · No verified English nameCXSL2300639 | Chengdu Rong Sheng Pharma Co., Ltd. romanized |
| 2023/09/21New drug · Class 2.4 | 注射用重组人凝血因子Ⅷ-Fc融合蛋白 · No verified English nameCXSL2300638 | Chengdu Rong Sheng Pharma Co., Ltd. romanized |
| 2023/09/21New drug · Class 1 | HG153片 · No verified English nameCXHL2301023 | Chengdu Xian Dao Drug Kai Fa Co., Ltd. romanized |
| 2023/09/21New drug · Class 1 | HG153片 · No verified English nameCXHL2301022 | Chengdu Xian Dao Drug Kai Fa Co., Ltd. romanized |
| 2023/09/20Generic · Class 3 | 醋酸钠林格葡萄糖注射液 · No verified English nameCYHS2302536 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2023/09/20Generic · Class 3 | 羧甲司坦糖浆 · No verified English nameCYHS2302535 | Anhui Mao Kang Pharma Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized |
| 2023/09/20Generic · Class 3 | 羧甲司坦糖浆 · No verified English nameCYHS2302534 | Anhui Mao Kang Pharma Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized |
| 2023/09/20Generic · Class 3 | Acetylcysteine InjectionCYHS2302530 | Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2023/09/20Generic · Class 3 | 硝唑尼特干混悬剂 · No verified English nameCYHL2300121 | Rui Yang Pharmaceutical Co., Ltd. romanized |
| 2023/09/20Generic · Class 3 | Glycopyrronium Bromide and Neostigmine Metilsulfate InjectionCYHL2300120 | Zhejiang Feng Hua Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/09/20New drug · Class 2.2 | 连花清咳颗粒 · No verified English nameCXZL2300062 | Shijiazhuang Yi Ling Pharma Co., Ltd. romanized |
| 2023/09/20New drug · Class 1 | 注射用人脐带间充质干细胞 · No verified English nameCXSL2300637 | Ai Er Pu Zai Sheng Yi Xue Technology (Shenzhen) Co., Ltd. romanized |
| 2023/09/20New drug · Class 1 | 注射用RB0021 · No verified English nameCXSL2300636 | Rui Yang (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/09/20New drug · Class 1 | GZR18片 · No verified English nameCXSL2300635 | Gan Li Pharma Shandong Co., Ltd. romanized |
| 2023/09/20New drug · Class 1 | GZR18片 · No verified English nameCXSL2300634 | Gan Li Pharma Shandong Co., Ltd. romanized |
| 2023/09/20New drug · Class 1 | GZR18片 · No verified English nameCXSL2300633 | Gan Li Pharma Shandong Co., Ltd. romanized |
| 2023/09/20New drug · Class 2.3 | SMF-216 · No verified English nameCXHL2301021 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2023/09/20New drug · Class 1 | BGB-26808片 · No verified English nameCXHL2301020 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/09/20New drug · Class 1 | BGB-26808片 · No verified English nameCXHL2301019 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/09/20New drug · Class 1 | BGB-26808片 · No verified English nameCXHL2301018 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
59 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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