YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 56 drug applications between 2 October 2023 and 8 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 13, covering 11 drug names.
2023/10/02 – 2023/10/08
- New acceptances this week
- 56
- Drugs with new generic filings (by drug name, de-duplicated)
- 11
- 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
56filings, 13 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 22 |
| Generic | 13 |
| New drug | 9 |
| Import re-registration | 8 |
| Import | 2 |
| Unspecified | 1 |
| Drug-device combination product | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 28 |
| TCM | 16 |
| Therapeutic biologic | 11 |
| Prophylactic 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
11 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Lacosamide Tablets | 2 | 1 | 0 |
| 2 | Iopromide Injection | 2 | 1 | 27 |
| 3 | Ibuprofen Sustained Release Capsules | 1 | 1 | 3 |
| 4 | Pregabalin Oral Solution | 1 | 1 | 5 |
| 5 | Famotidine Injection | 1 | 1 | 8 |
| 6 | 注射用亚胺培南西司他丁钠/氯化钠注射液 · No verified English name | 1 | 1 | 0 |
| 7 | Ceftazidime And Avibactam Sodium For Injection | 1 | 1 | 12 |
| 8 | 洛索洛芬钠凝胶贴膏 · No verified English name | 1 | 1 | 9 |
| 9 | 盐酸毛果芸香碱滴眼液 · No verified English name | 1 | 1 | 5 |
| 10 | Hydroxychloroquine Sulfate Tablets | 1 | 1 | 2 |
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
40 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Eli Lilly Nederland B.V. | 4 | 1 | 0 |
| 2 | Jiangxi Qing Feng Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 3 | Chongqing Xi Er An Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 4 | Chugai Pharmaceutical Co. Ltd | 3 | 1 | 0 |
| 5 | Shanxi Fu Sheng Gong Da Pharmaceutical Factory Co., Ltd. romanized | 2 | 2 | 0 |
| 6 | Guangzhou Yue Hua Pharmaceutical Co., Ltd. romanized | 2 | 2 | 0 |
| 7 | Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 2 | 1 | 2 |
| 8 | Beijing SL Pharmaceutical Co., Ltd. | 2 | 1 | 0 |
| 9 | Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized | 2 | 1 | 2 |
| 10 | Hangzhou Yu Hong Pharmaceuticals Technology Co., Ltd. romanized | 2 | 1 | 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
13 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/10/08Import · Class 1 | Tiragolumab注射液 · No verified English nameJXSL2300172 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2023/10/08Generic · Class 3 | Famotidine InjectionCYHS2302636 | Chengdu Gui He Technology Co., Ltd. romanized; Chengdu Li Er Pharma Co., Ltd. romanized |
| 2023/10/08Generic · Class 3 | Pregabalin Oral SolutionCYHS2302626 | Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized |
| 2023/10/08Generic · Class 3 | 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2300125 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD. |
| 2023/10/08New drug · Class 1 | BAT1308注射液 · No verified English nameCXSL2300669 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2023/10/08New drug · Class 1 | SNC109注射液 · No verified English nameCXSL2300668 | Shanghai Xian Bo Bio Technology Co., Ltd. romanized |
| 2023/10/08New drug · Class 1.4 | 24价肺炎球菌多糖结合疫苗 · No verified English nameCXSL2300667 | Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized; Beijing Ke Xing Bio Zhi Pin Co., Ltd. romanized |
| 2023/10/08New drug · Class 1 | 注射用SKB264 · No verified English nameCXSL2300666 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2023/10/08New drug · Class 1 | 注射用FTL008.16 · No verified English nameCXSL2300665 | Fei Tong (Chengdu) Bio Technology Co., Ltd. romanized |
| 2023/10/08New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2300664 | Guizhou Zhong Guan Bio Technology Co., Ltd. romanized |
| 2023/10/08New drug · Class 2.3 | SMF-209 · No verified English nameCXHL2301043 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2023/10/08New drug · Class 1 | YH001胶囊 · No verified English nameCXHL2301042 | Hangzhou Yu Hong Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/10/08New drug · Class 1 | YH001胶囊 · No verified English nameCXHL2301041 | Hangzhou Yu Hong Pharmaceuticals Technology Co., Ltd. romanized |
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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