YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 351 drug applications between 28 October 2023 and 3 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 54 drug names.
2023/10/28 – 2023/11/03
- New acceptances this week
- 351
- Drugs with new generic filings (by drug name, de-duplicated)
- 54
- 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
351filings, 70 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 179 |
| Generic | 70 |
| New drug | 69 |
| Import re-registration | 20 |
| Import | 8 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 236 |
| TCM | 62 |
| Therapeutic biologic | 45 |
| Prophylactic biologic | 5 |
| Biologic | 3 |
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
54 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Piracetam Injection | 4 | 2 | 9 |
| 2 | Benidipine Hydrochloride Tablets | 3 | 2 | 4 |
| 3 | Minoxidil Liniment | 3 | 2 | 52 |
| 4 | Perindopril tert-Butylamine Tablets | 3 | 1 | 5 |
| 5 | Betamethasone Sodium Phosphate Injection | 2 | 1 | 5 |
| 6 | Procaterol Hydrochloride Solution for Inhalation | 2 | 1 | 2 |
| 7 | Doxofylline Tablets | 2 | 1 | 2 |
| 8 | Brivaracetam Tablets | 2 | 1 | 19 |
| 9 | Potassium Chloride Granules | 2 | 1 | 4 |
| 10 | Roxadustat Capsules | 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
205 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanxi Shuang Yan Pharma Co., Ltd. romanized | 28 | 9 | 0 |
| 2 | Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 3 | Guangdong Tuan Li Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 5 | Janssen-Cilag International NV | 5 | 2 | 0 |
| 6 | Merck Sharp & Dohme B.V. | 5 | 1 | 0 |
| 7 | Haerbin Han Bang Medical Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 8 | Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Wuhan Bin Hu Shuang He Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Shanghai Bio Zhi Pin Research Institute 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
110 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/11/03Import · Class 1 | 盐酸BAY 3283142片 · No verified English nameJXHL2300271 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2023/11/03Import · Class 1 | 盐酸BAY 3283142片 · No verified English nameJXHL2300270 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2023/11/03Generic · Class 3 | Glycerol Fructose And Sodium Chloride InjectionCYHS2302989 | Hubei Mei Lin Pharma Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2023/11/03Generic · Class 3 | 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2302987 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/11/03Generic · Class 3 | Potassium Chloride InjectionCYHS2302986 | Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2023/11/03New drug · Class 1 | 伊基奥仑赛注射液 · No verified English nameCXSL2300759 | Nanjing Xun Lu Biopharmaceuticals Co., Ltd. romanized |
| 2023/11/03New drug · Class 1 | PD-1基因编辑T细胞注射液 · No verified English nameCXSL2300758 | Mei Jie Sai Er (Beijing) Bio Technology Co., Ltd. romanized |
| 2023/11/03New drug · Class 1 | YTS104细胞注射液 · No verified English nameCXSL2300757 | Hua Xia Ying Tai (Beijing) Bio Technology Co., Ltd. romanized |
| 2023/11/03New drug · Class 1 | BST02注射液 · No verified English nameCXSL2300756 | Guangzhou Bai Ji Biopharmaceutical Co., Ltd. romanized |
| 2023/11/03New drug · Class 1 | ARC01注射液 · No verified English nameCXSL2300755 | Nanjing Ao Luo Bio Technology Co., Ltd. romanized |
| 2023/11/03New drug · Class 1 | TQB3909片 · No verified English nameCXHL2301214 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/11/03New drug · Class 1 | HY-0902片 · No verified English nameCXHL2301213 | Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized; Shandong University romanized |
| 2023/11/03New drug · Class 1 | HY-0902片 · No verified English nameCXHL2301212 | Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized; Shandong University romanized |
| 2023/11/03New drug · Class 2.3 | Y-4片 · No verified English nameCXHL2301211 | Nanjing Ning Dan Xin Yao Technology Co., Ltd. romanized |
| 2023/11/03New drug · Class 2.3 | Y-4片 · No verified English nameCXHL2301210 | Nanjing Ning Dan Xin Yao Technology Co., Ltd. romanized |
| 2023/11/03New drug · Class 2.4 | Azacitidine For InjectionCXHL2301209 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/11/03New drug · Class 1 | XH-S004片 · No verified English nameCXHL2301207 | Zhejiang Xing Hao Peng Bo Pharmaceuticals Co., Ltd. romanized |
| 2023/11/02Import · Class 1 | Amlitelimab注射液 · No verified English nameJXSL2300190 | Sanofi-Aventis Recherche & Développement; Sanofi(China) Investment Co. LTD |
| 2023/11/02Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2302985 | Name not romanized; Jiangxi Dong Fu Pharmaceutical Co., Ltd. romanized |
| 2023/11/02Generic · Class 3 | Ferrous Succinate TabletsCYHS2302983 | Jiangsu Zhong Tian Pharma Co., Ltd. romanized |
| 2023/11/02Generic · Class 3 | Methocarbamol InjectionCYHS2302977 | Jiangsu Shen Long Pharma Co., Ltd. romanized |
| 2023/11/02Generic · Class 3 | Acetylcysteine InjectionCYHS2302976 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2023/11/02Generic · Class 3 | Minoxidil LinimentCYHS2302974 | Le Tai Pharma Co., Ltd. romanized; Le Tai Pharma (Lan Xi) Co., Ltd. romanized |
| 2023/11/02Generic · Class 3 | Minoxidil LinimentCYHS2302973 | Le Tai Pharma Co., Ltd. romanized; Le Tai Pharma (Lan Xi) Co., Ltd. romanized |
| 2023/11/02Generic · Class 3 | Minoxidil LinimentCYHS2302972 | Le Xin Le Mei (Hainan) Bio Technology Co., Ltd. romanized; Su Zhou Yi Fan Pharma Co., Ltd. romanized |
| 2023/11/02Generic · Class 3 | Brivaracetam TabletsCYHL2300134 | Chengdu Ao Bang Pharma Co., Ltd. romanized |
| 2023/11/02Generic · Class 3 | Brivaracetam TabletsCYHL2300133 | Chengdu Ao Bang Pharma Co., Ltd. romanized |
| 2023/11/02New drug · Class 3.1 | 温经汤颗粒 · No verified English nameCXZS2300022 | Guo Yao Group De Zhong (Fo Shan) Pharma Co., Ltd. romanized |
| 2023/11/02New drug · Class 1.1 | 莎毕娅片 · No verified English nameCXZL2300068 | Zhongguo Ke College Xinjiang Li Hua Technology Research Institute romanized |
| 2023/11/02New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2300754 | Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized |
80 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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