YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 414 drug applications between 30 November 2024 and 6 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 137, covering 102 drug names.
2024/11/30 – 2024/12/06
- New acceptances this week
- 414
- Drugs with new generic filings (by drug name, de-duplicated)
- 102
- Accepted this week, now under review
- 10
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
414filings, 137 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 184 |
| Generic | 137 |
| New drug | 70 |
| Import | 11 |
| Unspecified | 7 |
| Import re-registration | 4 |
| Drug-device combination | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 283 |
| TCM | 69 |
| Therapeutic biologic | 53 |
| Biologic | 5 |
| Prophylactic biologic | 3 |
| In vitro diagnostic reagent | 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
102 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Lactulose Oral Solution | 5 | 1 | 34 |
| 2 | Ambroxol Hydrochloride Oral Solution | 4 | 1 | 46 |
| 3 | Tadalafil Tablets | 3 | 2 | 23 |
| 4 | Oxcarbazepine Extended-release Tablets | 3 | 1 | 0 |
| 5 | Procaterol Hydrochloride Granules | 3 | 1 | 2 |
| 6 | Polymyxin B sulfate for Injection | 2 | 2 | 6 |
| 7 | Isavuconazonium Sulfate for Injection | 2 | 2 | 15 |
| 8 | Sodium Hyaluronate Eye Drops | 2 | 2 | 30 |
| 9 | 复方电解质醋酸钠葡萄糖注射液 · No verified English name | 2 | 1 | 22 |
| 10 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
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
253 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Heilongjiang Sheng Bu Jia Tang Pharma Co., Ltd. romanized | 13 | 13 | 0 |
| 2 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 9 | 3 | 0 |
| 3 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 6 | 5 | 2 |
| 4 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 6 | 2 | 0 |
| 5 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 6 | 2 | 0 |
| 6 | Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 5 | 5 | 5 |
| 7 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 5 | 4 | 5 |
| 8 | Ren He Yi Kang Group Co., Ltd. romanized | 5 | 2 | 2 |
| 9 | The Wellcome Foundation Limited | 5 | 1 | 0 |
| 10 | Shaanxi Xing Bang Pharma Co., Ltd. romanized | 5 | 1 | 5 |
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
131 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/12/06Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2404234 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2024/12/06Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2404233 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2024/12/06Generic · Class 3 | Progesterone InjectionCYHS2404227 | Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized; Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized |
| 2024/12/06Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2404225 | Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2024/12/06Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2404224 | Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2024/12/06Generic · Class 3 | Terbutaline Sulfate InjectionCYHS2404218 | Xian Da Mo Pharmaceutical Co., Ltd. romanized; Shaanxi Jin Si Ming Bio Technology Co., Ltd. romanized |
| 2024/12/06Generic · Class 3 | Indocyaninegreen for InjectionCYHS2404217 | Jiangsu Jiu Xu Pharma Co., Ltd. romanized |
| 2024/12/06Generic · Class 3 | Terbutaline Sulfate InjectionCYHS2404216 | Xian Da Mo Pharmaceutical Co., Ltd. romanized; Shaanxi Jin Si Ming Bio Technology Co., Ltd. romanized |
| 2024/12/06Generic · Class 3 | Sodium Cromoglicate Eye DropsCYHS2404207 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2024/12/06Generic · Class 3 | 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2400248 | Hua Run San Jiu (Ya An) Pharma Co., Ltd. romanized |
| 2024/12/06New drug · Class 1 | IBI3002 · No verified English nameCXSL2400832 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2024/12/06New drug · Class 1 | 注射用SLN12140 · No verified English nameCXSL2400831 | Ling Nuo (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/06New drug · Class 1 | HX009注射液 · No verified English nameCXSL2400830 | Hangzhou Han Si Biopharmaceuticals Co., Ltd. romanized |
| 2024/12/06New drug · Class 1 | SCTT11注射液 · No verified English nameCXSL2400829 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2024/12/06New drug · Class 1 | 注射用YL201 · No verified English nameCXSL2400828 | Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized |
| 2024/12/06New drug · Class 1 | KN060注射液 · No verified English nameCXSL2400827 | Suzhou Kang Ning Jie Rui Bio Technology Co., Ltd. romanized |
| 2024/12/06New drug · Class 2.2 | LNH2116-X1 · No verified English nameCXHL2401326 | Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized |
| 2024/12/06New drug · Class 1 | 康太替尼片 · No verified English nameCXHL2401325 | Shou Yao Holding (Beijing) Co., Ltd. romanized |
| 2024/12/06New drug · Class 1 | 康太替尼片 · No verified English nameCXHL2401324 | Shou Yao Holding (Beijing) Co., Ltd. romanized |
| 2024/12/06New drug · Class 1 | SY-5933片 · No verified English nameCXHL2401323 | Shou Yao Holding (Beijing) Co., Ltd. romanized |
| 2024/12/06New drug · Class 1 | XZP-7797-H1片 · No verified English nameCXHL2401322 | Xuan Zhu Bio Technology Co., Ltd. romanized; Shandong Xuan Zhu Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/06New drug · Class 1 | XZP-7797-H1片 · No verified English nameCXHL2401321 | Xuan Zhu Bio Technology Co., Ltd. romanized; Shandong Xuan Zhu Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/05Import · Class 1 | PF-07934040片 · No verified English nameJXHL2400286 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2024/12/05Import · Class 1 | PF-07934040片 · No verified English nameJXHL2400285 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2024/12/05Import · Class 1 | PF-07934040片 · No verified English nameJXHL2400284 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2024/12/05Generic · Class 3 | 多索茶碱口服溶液 · No verified English nameCYHS2404206 | Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2024/12/05Generic · Class 3 | Sevelamer Carbonate Powder for oral suspensionCYHS2404201 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
| 2024/12/05Generic · Class 3 | Gabexate Mesilate For InjectionCYHS2404194 | Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2024/12/05Generic · Class 3 | Oxcarbazepine Extended-release TabletsCYHL2400247 | Wuhan Ren Fu Li Kang Pharma Co., Ltd. romanized |
| 2024/12/05Generic · Class 3 | Oxcarbazepine Extended-release TabletsCYHL2400246 | Wuhan Ren Fu Li Kang Pharma Co., Ltd. romanized |
101 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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