YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 347 drug applications between 25 February 2025 and 3 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 83, covering 68 drug names.
2025/02/25 – 2025/03/03
- New acceptances this week
- 347
- Drugs with new generic filings (by drug name, de-duplicated)
- 68
- 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
347filings, 83 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 196 |
| Generic | 83 |
| New drug | 38 |
| Import | 16 |
| Unspecified | 8 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 219 |
| TCM | 83 |
| Therapeutic biologic | 34 |
| Prophylactic biologic | 6 |
| Biologic | 4 |
| 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
68 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dapagliflozin Tablets | 4 | 2 | 84 |
| 2 | Oxaliplatin Injection | 3 | 1 | 4 |
| 3 | Bromhexine Hydrochloride Injection | 2 | 2 | 8 |
| 4 | Lactulose Oral Solution | 2 | 1 | 34 |
| 5 | Ibrutinib Tablets | 2 | 1 | 0 |
| 6 | Procaterol Hydrochloride Solution for Inhalation | 2 | 1 | 2 |
| 7 | Cefuroxime Sodium for Injection | 2 | 1 | 8 |
| 8 | Lysine Acetylsalicylate For Injection | 2 | 1 | 8 |
| 9 | 盐酸丙卡特罗吸入溶液 · No verified English name | 2 | 1 | 3 |
| 10 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 2 | 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
203 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Heilongjiang Lin Hai Xue Yuan Pharma Co., Ltd. romanized | 24 | 22 | 0 |
| 2 | Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 16 | 9 | 0 |
| 3 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 10 | 3 | 0 |
| 4 | Guizhou San Ren Tang Pharma Co., Ltd. romanized | 8 | 8 | 0 |
| 5 | Heilongjiang Sheng Bu Jia Tang Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | Shanghai Bei Jie Group Guan Dong Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Boehringer Ingelheim International GmbH | 5 | 4 | 0 |
| 8 | Heilongjiang Han Hong Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Chongqing Xi Er An Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Baxter Holding B.V. | 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
91 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/03/03Generic · Class 3 | 醋酸地非法林注射液 · No verified English nameCYHS2500902 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2025/03/03Generic · Class 3 | 头孢地尼干混悬剂 · No verified English nameCYHS2500901 | Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Sichuan Sai Zhuo Pharma Co., Ltd. romanized |
| 2025/03/03Generic · Class 3 | Sevelamer Carbonate Powder for oral suspensionCYHS2500900 | Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized; Hubei Hua Shi Tong Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/03/03Generic · Class 3 | Sevelamer Carbonate Powder for oral suspensionCYHS2500899 | Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized; Hubei Hua Shi Tong Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/03/03Generic · Class 3 | Ursodeoxycholic Acid GranulesCYHS2500897 | Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized |
| 2025/03/03Generic · Class 3 | 阿瑞匹坦注射液 · No verified English nameCYHS2500896 | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. |
| 2025/03/03Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2500895 | Hubei Jin Yao Pharma Co., Ltd. romanized |
| 2025/03/03Generic · Class 3 | Relugolix TabletsCYHL2500055 | Shanxi Zhen Dong Pharmaceutical Co., Ltd. romanized |
| 2025/03/03New drug · Class 2.3 | SMF-217 · No verified English nameCXHL2500233 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2025/03/01Import · Class 2.2 | CHF5993-II · No verified English nameJXHL2500032 | Chiesi Farmaceutici S.p.A.; Chiesi Pharmaceutical Consulting (Shanghai) Co. Ltd. |
| 2025/03/01Generic · Class 3 | Ibrutinib TabletsCYHS2500891 | Chongqing Huapont Pharmaceutical Co., Ltd. |
| 2025/03/01Generic · Class 3 | Ibrutinib TabletsCYHS2500890 | Chongqing Huapont Pharmaceutical Co., Ltd. |
| 2025/03/01Generic · Class 3 | 盐酸丙卡特罗吸入溶液 · No verified English nameCYHS2500889 | Jiangsu Vanguard Pharmaceutical Co., Ltd. |
| 2025/03/01Generic · Class 3 | 盐酸丙卡特罗吸入溶液 · No verified English nameCYHS2500888 | Jiangsu Vanguard Pharmaceutical Co., Ltd. |
| 2025/03/01Generic · Class 3 | 聚乙二醇4000散(儿童型) · No verified English nameCYHS2500885 | Hefei Sheng Qin Pharmaceuticals Technology Co., Ltd. romanized; Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized |
| 2025/03/01New drug · Class 1 | IMB071703注射液 · No verified English nameCXSL2500189 | Beijing Mian Yi Fang Zhou Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/03/01New drug · Class 1 | LBM801 · No verified English nameCXSL2500188 | Shanghai Li Kang Rui Bio Gong Cheng Co., Ltd. romanized; Shanghai Bo Sai Mei Bio Technology Co., Ltd. romanized |
| 2025/03/01New drug · Class 1 | 注射用Neu-001 · No verified English nameCXHL2500232 | Shen Zhan Pharmaceuticals (Shenzhen) Co., Ltd. romanized |
| 2025/03/01New drug · Class 2.4 | TAP-1503 乳膏 · No verified English nameCXHL2500231 | Shanghai Ze De Man Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/02/28Generic · Class 3 | Ferrous Succinate TabletsCYHS2500883 | Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized |
| 2025/02/28Generic · Class 3 | Bifonazole SolutionCYHS2500881 | Tang Shan Hong Xing Pharma Co., Ltd. romanized |
| 2025/02/28Generic · Class 3 | 苯磺酸氨氯地平口服溶液 · No verified English nameCYHS2500880 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
| 2025/02/28Generic · Class 3 | Oxaliplatin InjectionCYHS2500879 | Hubei Yi Ban Tian Pharmaceutical Co., Ltd. romanized |
| 2025/02/28Generic · Class 3 | Oxaliplatin InjectionCYHS2500878 | Hubei Yi Ban Tian Pharmaceutical Co., Ltd. romanized |
| 2025/02/28Generic · Class 3 | Oxaliplatin InjectionCYHS2500877 | Hubei Yi Ban Tian Pharmaceutical Co., Ltd. romanized |
| 2025/02/28Generic · Class 3 | Brivaracetam Oral SolutionCYHS2500876 | Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/02/28Generic · Class 3 | 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2500872 | Hefei Sheng Qin Pharmaceuticals Technology Co., Ltd. romanized; Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized |
| 2025/02/28Generic · Class 3 | Metronidazole Vaginal GelCYHL2500053 | Hua Kong Innovation (Beijing) Drug Research Institute Co., Ltd. romanized |
| 2025/02/28New drug · Class 3.1 | 半夏泻心汤颗粒 · No verified English nameCXZS2500010 | Shanxi Guang Yu Yuan Guo Yao Co., Ltd. romanized |
| 2025/02/28New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2500187 | Beijing Tuo Hua Wei Ye Bio Technology 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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