YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 536 drug applications between 7 October 2023 and 13 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 136, covering 101 drug names.
2023/10/07 – 2023/10/13
- New acceptances this week
- 536
- Drugs with new generic filings (by drug name, de-duplicated)
- 101
- 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
536filings, 136 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 238 |
| Generic | 136 |
| New drug | 105 |
| Import | 26 |
| Import re-registration | 20 |
| Unspecified | 10 |
| Drug-device combination product | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 388 |
| TCM | 70 |
| Therapeutic biologic | 70 |
| Prophylactic biologic | 8 |
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
101 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Edoxaban Tosilate Tablets | 6 | 2 | 9 |
| 2 | Diquafosol Sodium Eye Drops | 4 | 4 | 5 |
| 3 | Lactulose Oral Solution | 4 | 3 | 34 |
| 4 | Famotidine Injection | 4 | 3 | 8 |
| 5 | Nicorandil for Injection | 3 | 2 | 1 |
| 6 | Minoxidil Liniment | 3 | 2 | 52 |
| 7 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 3 | 1 | 2 |
| 8 | Betamethasone Sodium Phosphate Injection | 2 | 2 | 5 |
| 9 | Compound Ipratropium Bromide Solution For Inhalation | 2 | 2 | 4 |
| 10 | Phenylephrine Hydrochloride Injection | 2 | 2 | 5 |
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
304 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 | 14 | 5 | 1 |
| 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 | Jiangsu En Hua Pharma Co., Ltd. romanized | 6 | 2 | 0 |
| 7 | Beijing Foyou Pharma CO.,LTD | 5 | 4 | 3 |
| 8 | Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 5 | 3 | 5 |
| 9 | Qilu Pharmaceutical Co., Ltd. | 5 | 3 | 5 |
| 10 | Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized | 5 | 2 | 1 |
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
177 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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. |
| 2023/10/13Import · Class 2.4 | Ritlecitinib胶囊 · No verified English nameJXHL2300254 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2023/10/13Import · Class 2.4 | Ritlecitinib胶囊 · No verified English nameJXHL2300253 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2023/10/13Import · Class 1 | LOU064片 · No verified English nameJXHL2300252 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2023/10/13Generic · Class 3 | Betamethasone Sodium Phosphate InjectionCYHS2302753 | Yu Song Yuan Pharma Co., Ltd. romanized |
| 2023/10/13Generic · Class 3 | Butorphanol Tartrate InjectionCYHS2302752 | Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2023/10/13Generic · Class 3 | Butorphanol Tartrate InjectionCYHS2302751 | Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2023/10/13Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2302746 | Luo Xin An Ruo Wei Ta Pharma (Chengdu) Co., Ltd. romanized |
| 2023/10/13Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2302745 | Luo Xin An Ruo Wei Ta Pharma (Chengdu) Co., Ltd. romanized |
| 2023/10/13Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2302744 | Luo Xin An Ruo Wei Ta Pharma (Chengdu) Co., Ltd. romanized |
| 2023/10/13Generic · Class 3 | Proparacaine Hydrochloride Eye DropsCYHS2302743 | Jiangxi Ma Ying Long Mei Kang Pharma Co., Ltd. romanized; Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized |
| 2023/10/13Generic · Class 3 | Diprophylline InjectionCYHS2302739 | Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2023/10/13Generic · Class 3 | Famotidine InjectionCYHS2302736 | Suzhou Lang Yi Biopharmaceuticals Research Co., Ltd. romanized; Gansu Cheng Ji Bio Pharma Co., Ltd. romanized |
| 2023/10/13Generic · Class 3 | Famotidine InjectionCYHS2302735 | Suzhou Lang Yi Biopharmaceuticals Research Co., Ltd. romanized; Gansu Cheng Ji Bio Pharma Co., Ltd. romanized |
| 2023/10/13Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2302734 | Heilongjiang Bo Yu Pharmaceutical Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2023/10/13Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2302733 | Heilongjiang Bo Yu Pharmaceutical Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2023/10/13Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2302732 | Sheng Jia (Bin Hai) Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized |
| 2023/10/13Generic · Class 3 | Relugolix TabletsCYHL2300130 | Shanghai Hui Lun Pharmaceuticals Co., Ltd. romanized |
| 2023/10/13Generic · Class 3 | 伏环孢素软胶囊 · No verified English nameCYHL2300129 | Qilu Pharmaceutical Co., Ltd. |
| 2023/10/13New drug · Class 2.2 | 替雷利珠单抗注射液 · No verified English nameCXSS2300086 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized; Bo Lin Ge Yin Ge Han Bio Pharma (Zhongguo) Co., Ltd. romanized |
| 2023/10/13New drug · Class 1 | ZX2010注射液 · No verified English nameCXSL2300697 | Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized |
| 2023/10/13New drug · Class 1 | 注射用SHR-A1921 · No verified English nameCXSL2300696 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2023/10/13New drug · Class 1 | 重组抗IL-17A人源化单克隆抗体注射液 · No verified English nameCXSL2300695 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2023/10/13New drug · Class 1 | 重组抗IL-17A人源化单克隆抗体注射液 · No verified English nameCXSL2300694 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2023/10/13New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2300693 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2023/10/13New drug · Class 2.2 | SHR-8068注射液 · No verified English nameCXSL2300692 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2023/10/13New drug · Class 1 | JMT601注射液 · No verified English nameCXSL2300691 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2023/10/13New drug · Class 2.1 | AK1012吸入用溶液 · No verified English nameCXSL2300690 | Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized |
147 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.