YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 325 drug applications between 12 November 2023 and 18 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 69, covering 52 drug names.
2023/11/12 – 2023/11/18
- New acceptances this week
- 325
- Drugs with new generic filings (by drug name, de-duplicated)
- 52
- 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
325filings, 69 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 187 |
| Generic | 69 |
| New drug | 38 |
| Import | 19 |
| Import re-registration | 7 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 223 |
| TCM | 63 |
| Therapeutic biologic | 35 |
| Biologic | 2 |
| Prophylactic biologic | 2 |
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
52 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Neostigmine Methylsulfate Injection | 5 | 2 | 4 |
| 2 | Potassium Chloride Granules | 4 | 2 | 4 |
| 3 | Dabigatran Etexilate Capsules | 3 | 1 | 2 |
| 4 | Gabapentin Capsules | 2 | 1 | 0 |
| 5 | Perindopril arginine and amlodipine besylate tablets | 2 | 1 | 3 |
| 6 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 7 | Famotidine Injection | 2 | 1 | 8 |
| 8 | 注射用头孢哌酮钠舒巴坦钠(2:1) · No verified English name | 2 | 1 | 2 |
| 9 | Minoxidil Liniment | 2 | 1 | 52 |
| 10 | Eldecalcitol Soft Capsules | 2 | 1 | 8 |
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
186 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanxi Shuang Yan Pharma Co., Ltd. romanized | 27 | 26 | 0 |
| 2 | Jiu Hua Hua Yuan Pharma Co., Ltd. romanized | 8 | 8 | 0 |
| 3 | AstraZeneca AB | 8 | 4 | 0 |
| 4 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 8 | 1 | 0 |
| 5 | Bao Guang Pharma (Chengdu) Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Shandong Er Ye Pharmaceutical Co., Ltd. romanized | 5 | 2 | 0 |
| 7 | Novo Nordisk A/S | 5 | 1 | 0 |
| 8 | Pfizer Europe MA EEIG | 4 | 2 | 0 |
| 9 | Guangzhou Yin Nuo Pharmaceuticals Group Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized | 3 | 3 | 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
84 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/11/18Generic · Class 3 | Arbidol Hydrochloride TabletsCYHS2303169 | Wuhan Ren Fu Li Kang Pharma Co., Ltd. romanized |
| 2023/11/18Generic · Class 3 | Cimetidine InjectionCYHS2303168 | Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized |
| 2023/11/18New drug · Class 2.3 | 小儿热速清口服液 · No verified English nameCXZL2300070 | Jilin Yi Zheng Pharma Group Co., Ltd. romanized |
| 2023/11/18New drug · Class 1 | BW-20507注射液 · No verified English nameCXHL2301283 | Hangzhou Bo Lin Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/18New drug · Class 2.1; 2.2; 2.4 | 盐酸(R)-氯胺酮鼻喷雾剂 · No verified English nameCXHL2301282 | Sichuan Pu Rui Te Pharma Co., Ltd. romanized |
| 2023/11/18New drug · Class 2.1; 2.2; 2.4 | 盐酸(R)-氯胺酮鼻喷雾剂 · No verified English nameCXHL2301281 | Sichuan Pu Rui Te Pharma Co., Ltd. romanized |
| 2023/11/17Import · Class 2.3 | Aztreonam and Avibactam Sodium for InjectionJXHS2300103 | Pfizer Europe MA EEIG; Hospira Australia Pty Ltd; Pfizer Investment Co. Ltd. |
| 2023/11/17Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2303156 | Lang Tian Pharmaceuticals Technology (Wuhan) Co., Ltd. romanized; Lang Tian Pharma (Hubei) Co., Ltd. romanized |
| 2023/11/17Generic · Class 3 | Polyvinyl Alcohol Eye DropsCYHS2303155 | Zhejiang Shi Fang Ji Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/11/17Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2303150 | Hebei Ke Yuan Pharma Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2023/11/17Generic · Class 3 | 美洛昔康纳米晶注射液 · No verified English nameCYHL2300139 | Jiangsu Hui Ju Pharma Co., Ltd. romanized |
| 2023/11/17New drug · Class 2.3 | 八宝丹胶囊 · No verified English nameCXZL2300069 | Xiamen Zhong Pharmaceutical Factory Co., Ltd. romanized |
| 2023/11/17New drug · Class 1 | ZVS203e 注射液 · No verified English nameCXSL2300790 | Beijing Zhong Yin Pharmaceutical Co., Ltd. romanized |
| 2023/11/17New drug · Class 1 | 注射用重组酰化胰高血糖素样肽2类似物 · No verified English nameCXSL2300789 | Chongqing Pai Jin Bio Technology Co., Ltd. romanized |
| 2023/11/17New drug · Class 1 | 靶向CD19的嵌合抗原受体基因修饰的NK细胞注射液 · No verified English nameCXSL2300788 | Shanghai Xian Bo Bio Technology Co., Ltd. romanized |
| 2023/11/17New drug · Class 1 | 靶向CD19的嵌合抗原受体基因修饰的NK细胞注射液 · No verified English nameCXSL2300787 | Shanghai Xian Bo Bio Technology Co., Ltd. romanized |
| 2023/11/17New drug · Class 1 | 靶向CD19的嵌合抗原受体基因修饰的NK细胞注射液 · No verified English nameCXSL2300786 | Shanghai Xian Bo Bio Technology Co., Ltd. romanized |
| 2023/11/17New drug · Class 1 | ZHB103注射液 · No verified English nameCXSL2300785 | Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized |
| 2023/11/17New drug · Class 2.4 | 注射用西罗莫司(白蛋白结合型) · No verified English nameCXHL2301280 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2023/11/17New drug · Class 2.2 | SXF-102口溶膜 · No verified English nameCXHL2301279 | Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized |
| 2023/11/17New drug · Class 2.2 | SXF-102口溶膜 · No verified English nameCXHL2301278 | Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized |
| 2023/11/17New drug · Class 2.4 | 奥布替尼片 · No verified English nameCXHL2301277 | Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/17New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2301276 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/11/17New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2301275 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/11/17New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2301274 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/11/16Generic · Class 3 | 复方聚乙二醇电解质散(儿童型) · No verified English nameCYHS2303146 | Hebei San He Shi Chuang Bio Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2023/11/16Generic · Class 3 | Metformin Hydrochloride Extended-release TabletsCYHS2303145 | Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized |
| 2023/11/16New drug · Class 2.2 | SHR-8068注射液 · No verified English nameCXSL2300784 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2023/11/16New drug · Class 1 | TQB2928注射液 · No verified English nameCXSL2300783 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/11/16New drug · Class 1 | LF0376片 · No verified English nameCXHL2301273 | Wuxi Ling Fang Biopharmaceuticals Technology Co., Ltd. romanized |
54 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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