YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 384 drug applications between 6 March 2026 and 12 March 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 38, covering 31 drug names.
2026/03/06 – 2026/03/12
- New acceptances this week
- 384
- Drugs with new generic filings (by drug name, de-duplicated)
- 31
- Accepted this week, now under review
- 105
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
384filings, 38 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 252 |
| New drug | 65 |
| Generic | 38 |
| Import | 12 |
| Import re-registration | 10 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 195 |
| TCM | 118 |
| Therapeutic biologic | 62 |
| Biologic | 5 |
| Prophylactic biologic | 4 |
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
31 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Cetitizine Hydrochloride Oral Solution | 3 | 1 | 6 |
| 2 | Polyvinyl Alcohol Eye Drops | 2 | 2 | 24 |
| 3 | Tacrolimus Capsules | 2 | 1 | 2 |
| 4 | Sacubitril Valsartan Sodium Tablets | 2 | 1 | 70 |
| 5 | 磷苯妥英钠注射用浓溶液 · No verified English name | 2 | 1 | 6 |
| 6 | Acetate And Glucose Electrolytes Injection | 2 | 1 | 4 |
| 7 | Acetylcysteine Injection | 1 | 1 | 53 |
| 8 | Acetylcysteine Tablets | 1 | 1 | 8 |
| 9 | Lactulose Oral Solution | 1 | 1 | 34 |
| 10 | Sodium Lactate Ringer's Irrigation Solution | 1 | 1 | 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
201 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bayer Vital GmbH | 16 | 1 | 0 |
| 2 | Hubei Ji An Tang Pharma Co., Ltd. romanized | 14 | 14 | 0 |
| 3 | Hong Ji Tang Pharmaceutical (Lai Wu Qu) Co., Ltd. romanized | 14 | 11 | 0 |
| 4 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized | 12 | 1 | 0 |
| 5 | Jiangxi Pu Li Er Pharma Co., Ltd. romanized | 11 | 10 | 0 |
| 6 | Hubei Yi Ban Tian Pharmaceutical Co., Ltd. romanized | 9 | 2 | 0 |
| 7 | Qilu Pharmaceutical Co., Ltd. | 6 | 5 | 0 |
| 8 | Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized | 6 | 4 | 0 |
| 9 | Heilongjiang Sheng Song Hua Jiang Pharmaceuticals Technology Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Karuna Therapeutics Inc. | 5 | 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
91 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/03/12Generic · Class 3 | Furosemide InjectionCYHS2600651 | Xin He Yuan Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/03/12Generic · Class 3 | Trazodone Hydrochloride TabletsCYHS2600647 | Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized |
| 2026/03/12New drug · Class 1 | JSKN021注射液 · No verified English nameCXSL2600327 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2026/03/12New drug · Class 2.2 | 重组人血小板生成素注射液 · No verified English nameCXSL2600325 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/03/12New drug · Class 2.2 | 重组人血小板生成素注射液 · No verified English nameCXSL2600324 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/03/12New drug · Class 1 | 人脐带间充质干细胞Ⅱ型注射液 · No verified English nameCXSL2600323 | Zhejiang Wo Wu Gan Xi Bao Technology Co., Ltd. romanized |
| 2026/03/12New drug · Class 2.2 | 氨酚羟考酮缓释片 · No verified English nameCXHS2600041 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2026/03/12New drug · Class 1 | QLC1101片 · No verified English nameCXHL2600305 | Qilu Pharmaceutical Co., Ltd. |
| 2026/03/12New drug · Class 2.4 | 氢溴酸氘瑞米德韦干混悬剂 · No verified English nameCXHL2600298 | Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhongguo Ke College Wuhan Bing Du Research Institute romanized |
| 2026/03/12New drug · Class 2.4 | 氢溴酸氘瑞米德韦干混悬剂 · No verified English nameCXHL2600297 | Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhongguo Ke College Wuhan Bing Du Research Institute romanized |
| 2026/03/12New drug · Class 1 | GCF20215 · No verified English nameCXHL2600296 | Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized |
| 2026/03/11Import · Class 1 | LY4005130注射液 · No verified English nameJXSL2600076 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2026/03/11Import · Class 1 | RO7589655注射液 · No verified English nameJXSL2600073 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/03/11Import · Class 1 | RO7589655注射液 · No verified English nameJXSL2600072 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/03/11Import · Class 1 | RO7589655注射液 · No verified English nameJXSL2600071 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/03/11Import · Class 1 | RO7589655注射液 · No verified English nameJXSL2600070 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/03/11Import · Class 1 | LY4005130注射液 · No verified English nameJXSL2600069 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2026/03/11Import · Class 2.4 | Adagrasib 片 · No verified English nameJXHL2600080 | Mirati Therapeutics Inc. a Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2026/03/11Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2600644 | Hunan Chun Jian Pharmaceutical Technology Co., Ltd. romanized; Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/03/11Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2600640 | Guizhou Qian Yao Group Pharmaceutical Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2026/03/11New drug · Class 2.2 | 卡度尼利单抗注射液 · No verified English nameCXSL2600322 | Kang Fang Pharma Co., Ltd. romanized |
| 2026/03/11New drug · Class 1 | 注射用BGB-B2033 · No verified English nameCXSL2600321 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2026/03/11New drug · Class 1 | IBI3005 · No verified English nameCXSL2600320 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/03/11New drug · Class 3.2 | 新型佐剂流感病毒裂解疫苗 · No verified English nameCXSL2600319 | Hua Lan Bio Yi Miao Co., Ltd. romanized |
| 2026/03/11New drug · Class 1 | IBI3014 · No verified English nameCXSL2600318 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/03/11New drug · Class 3.3 | 人生长激素注射液 · No verified English nameCXSL2600317 | Jun He Meng Biopharmaceutical (Hangzhou) Co., Ltd. romanized |
| 2026/03/11New drug · Class 1 | 硫酸益母草碱片 · No verified English nameCXHL2600295 | Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized |
| 2026/03/11New drug · Class 1 | 硫酸益母草碱片 · No verified English nameCXHL2600294 | Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized |
| 2026/03/11New drug · Class 1 | 硫酸益母草碱片 · No verified English nameCXHL2600293 | Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized |
| 2026/03/11New drug · Class 1 | 硫酸益母草碱片 · No verified English nameCXHL2600292 | Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized |
61 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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