YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 329 drug applications between 28 August 2024 and 3 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 102, covering 78 drug names.
2024/08/28 – 2024/09/03
- New acceptances this week
- 329
- Drugs with new generic filings (by drug name, de-duplicated)
- 78
- Accepted this week, now under review
- 1
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
329filings, 102 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 148 |
| Generic | 102 |
| New drug | 63 |
| Import | 9 |
| Unspecified | 5 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 226 |
| TCM | 58 |
| Therapeutic biologic | 37 |
| Prophylactic biologic | 8 |
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
78 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Bumetanide Injection | 4 | 2 | 13 |
| 2 | Rivaroxaban Tablets | 4 | 1 | 3 |
| 3 | 维生素B6注射液 · No verified English name | 3 | 3 | 10 |
| 4 | Tadalafil Tablets | 3 | 1 | 23 |
| 5 | Gadobutrol Injection | 3 | 1 | 8 |
| 6 | Lactated Ringer's Injection | 2 | 1 | 5 |
| 7 | 依伏卡塞片 · No verified English name | 2 | 1 | 9 |
| 8 | Empagliflozin Tablets | 2 | 1 | 18 |
| 9 | Sildenafil Citrate Tablets | 2 | 1 | 12 |
| 10 | Nafamostat Mesilate for Injection | 2 | 1 | 38 |
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
212 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Zhen Yuan Pharmaceutical Co., Ltd. romanized | 6 | 5 | 0 |
| 2 | Jilin Xin Wan Lian Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 3 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized | 5 | 2 | 0 |
| 4 | Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized | 4 | 4 | 4 |
| 5 | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Guizhou Liang Ji Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Qingdao Dong Hai Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized | 4 | 2 | 4 |
| 9 | Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized | 4 | 1 | 4 |
| 10 | Jiangsu En Hua Pharma Co., Ltd. romanized | 4 | 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
105 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/09/03Import · Class 1 | AMG 193 · No verified English nameJXHL2400211 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2024/09/03Generic · Class 3 | Famotidine InjectionCYHS2402887 | Suzhou Hong Sen Pharma Co., Ltd. romanized |
| 2024/09/03Generic · Class 3 | Bilastine Orally disintegrating TabletsCYHS2402884 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
| 2024/09/03Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2402879 | Shanxi Kang Cheng Li An Pharmaceuticals Co., Ltd. romanized; Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized |
| 2024/09/03New drug · Class 1 | 注射用艾帕依泊汀α · No verified English nameCXSS2400094 | Sichuan Lu Zhou Bu Zhang Biopharmaceutical Co., Ltd. romanized |
| 2024/09/03New drug · Class 1 | 注射用艾帕依泊汀α · No verified English nameCXSS2400093 | Sichuan Lu Zhou Bu Zhang Biopharmaceutical Co., Ltd. romanized |
| 2024/09/03New drug · Class 1 | SM3321注射液 · No verified English nameCXSL2400586 | Beijing Shuo Xing Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/09/03New drug · Class 1 | 9MW2821 · No verified English nameCXSL2400585 | Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized |
| 2024/09/03New drug · Class 3.3 | 吸附破伤风疫苗 · No verified English nameCXSL2400584 | Yunnan Wo Sen Bio Technology Co., Ltd. romanized; Yu Xi Wo Sen Bio Technology Co., Ltd. romanized |
| 2024/09/03New drug · Class 1 | NH160030片 · No verified English nameCXHL2400899 | Jiangsu En Hua Pharma Co., Ltd. romanized; Shanghai Shu Jing Bio Technology Co., Ltd. romanized |
| 2024/09/03New drug · Class 1 | NH160030片 · No verified English nameCXHL2400898 | Jiangsu En Hua Pharma Co., Ltd. romanized; Shanghai Shu Jing Bio Technology Co., Ltd. romanized |
| 2024/09/03New drug · Class 1 | NH160030片 · No verified English nameCXHL2400897 | Jiangsu En Hua Pharma Co., Ltd. romanized; Shanghai Shu Jing Bio Technology Co., Ltd. romanized |
| 2024/09/03New drug · Class 1 | NH160030片 · No verified English nameCXHL2400896 | Jiangsu En Hua Pharma Co., Ltd. romanized; Shanghai Shu Jing Bio Technology Co., Ltd. romanized |
| 2024/09/02New drug · Class 3.1 | 二冬颗粒 · No verified English nameCXZS2400029 | Shen Wei Pharma Group Co., Ltd. romanized |
| 2024/09/02New drug · Class 1 | ALMB-0168注射液 · No verified English nameCXSL2400582 | Shanghai En Le Mai Bio Technology Co., Ltd. romanized |
| 2024/09/02New drug · Class 1 | 人生长激素-Fc融合蛋白注射液 · No verified English nameCXSL2400581 | Changchun Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2024/09/02New drug · Class 2.2 | 尼莫地平注射用浓溶液 · No verified English nameCXHL2400895 | Beijing De Li Fu Rui Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/09/02New drug · Class 1 | RAY1225注射液 · No verified English nameCXHL2400894 | Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized |
| 2024/09/01Generic · Class 3 | 中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2402869 | Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized |
| 2024/09/01Generic · Class 3 | 中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2402868 | Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized |
| 2024/09/01Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2402867 | Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized |
| 2024/09/01Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2402866 | Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized |
| 2024/08/31Import · Class 2.4 | Sulfur Hexafluoride Microbubbles for InjectionJXHS2400060 | Bracco International B.V.; Bracco Suisse SA; Bracco Imaging Medical Technologies (Shanghai) Co. Ltd |
| 2024/08/31Generic · Class 3 | 氯化钙注射液 · No verified English nameCYHS2402865 | Shijiazhuang Xing Ze Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2024/08/31Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2402860 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2024/08/31Generic · Class 3 | Emedastine Difumarate Sustained-release CapsulesCYHS2402858 | Hunan Pu Dao Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2024/08/31Generic · Class 3 | Revefenacin inhalation solutionCYHL2400182 | Zhang Feng Pharma Co., Ltd. romanized |
| 2024/08/31New drug · Class 1.1 | 玉蚕颗粒 · No verified English nameCXZL2400049 | Wuhan Ren Fu Innovation Drug Research and Development Center Co., Ltd. romanized; Shanghai Fu Huo Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/08/31New drug · Class 1.1 | 膝痛颗粒 · No verified English nameCXZL2400048 | Zhong Yi (Guangzhou) Technology Innovation Research Co., Ltd. romanized; Zhongguo Zhong Yi Ke College Zhong Yao Research Institute romanized |
| 2024/08/31New drug · Class 3.3 | 冻干人用狂犬病疫苗(人二倍体细胞) · No verified English nameCXSS2400092 | Cheng Da Bio (Ben Xi) Co., Ltd. romanized |
75 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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