YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 325 drug applications between 5 March 2025 and 11 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 97, covering 70 drug names.
2025/03/05 – 2025/03/11
- New acceptances this week
- 325
- Drugs with new generic filings (by drug name, de-duplicated)
- 70
- Accepted this week, now under review
- 9
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, 97 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 140 |
| Generic | 97 |
| New drug | 49 |
| Import | 18 |
| Import re-registration | 12 |
| Unspecified | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 252 |
| Therapeutic biologic | 36 |
| TCM | 31 |
| Prophylactic biologic | 6 |
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
70 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Brexpiprazole Tablets | 5 | 2 | 31 |
| 2 | Sacubitril Valsartan Sodium Tablets | 5 | 2 | 70 |
| 3 | Polidocanol Injection | 5 | 2 | 23 |
| 4 | Bisoprolol Fumarate and Amlodipine Besylate Tablets | 2 | 2 | 9 |
| 5 | 洛索洛芬钠凝胶贴膏 · No verified English name | 2 | 2 | 9 |
| 6 | Loxoprofen Sodium Oral Solution | 2 | 2 | 6 |
| 7 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 8 | Acipimox Capsules | 2 | 2 | 2 |
| 9 | Multiple Vitamins Injection | 2 | 1 | 4 |
| 10 | Levetiracetam Tablets | 2 | 1 | 6 |
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
197 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized | 17 | 17 | 0 |
| 2 | Fresenius Kabi Deutschland GmbH | 9 | 1 | 0 |
| 3 | Bayer AG | 6 | 3 | 0 |
| 4 | Novo Nordisk A/S | 5 | 1 | 0 |
| 5 | Nanjing San Die Ji Pharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 6 | Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Qilu Pharmaceutical Co., Ltd. | 4 | 3 | 0 |
| 8 | Sichuan Pu Rui Te Pharma Co., Ltd. romanized | 4 | 2 | 1 |
| 9 | Bayer Vital GmbH | 4 | 1 | 0 |
| 10 | CHEPLAPHARM Schweiz GmbH | 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
90 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/03/11Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSL2500036 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2025/03/11Generic · Class 3 | Multiple Vitamins InjectionCYHS2501006 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2025/03/11Generic · Class 3 | Multiple Vitamins InjectionCYHS2501005 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2025/03/11Generic · Class 3 | Multiple Electrolyte Additive For InjectionCYHS2501002 | Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2025/03/11Generic · Class 3 | 甲氧氯普胺片 · No verified English nameCYHS2500997 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized |
| 2025/03/11Generic · Class 3 | 甲氧氯普胺片 · No verified English nameCYHS2500996 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized |
| 2025/03/11New drug · Class 2.1; 2.2 | 泰它西普注射液 · No verified English nameCXSL2500219 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2025/03/11New drug · Class 2.2 | 帕尼单抗注射液 · No verified English nameCXSL2500218 | Qilu Pharmaceutical Co., Ltd. |
| 2025/03/11New drug · Class 2.2 | QL2107注射液 · No verified English nameCXSL2500217 | Qilu Pharmaceutical Co., Ltd. |
| 2025/03/11New drug · Class 2.2 | 注射用MK-2870 · No verified English nameCXSL2500216 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2025/03/11New drug · Class 1 | RGT-274-CR胶囊 · No verified English nameCXHL2500268 | Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2025/03/11New drug · Class 1 | RGT-274-CR胶囊 · No verified English nameCXHL2500267 | Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2025/03/11New drug · Class 1 | RGT-274-CR胶囊 · No verified English nameCXHL2500266 | Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2025/03/11New drug · Class 1 | GCJ490-A片 · No verified English nameCXHL2500265 | Yan Tai Drug Research Institute romanized; Yan Tai Xin Yao Chuang Zhi Shandong Sheng Laboratory romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized |
| 2025/03/11New drug · Class 1 | GCJ490-A片 · No verified English nameCXHL2500264 | Yan Tai Drug Research Institute romanized; Yan Tai Xin Yao Chuang Zhi Shandong Sheng Laboratory romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized |
| 2025/03/11New drug · Class 1 | QLC1101胶囊 · No verified English nameCXHL2500263 | Qilu Pharmaceutical Co., Ltd. |
| 2025/03/11New drug · Class 1 | QLC1101胶囊 · No verified English nameCXHL2500262 | Qilu Pharmaceutical Co., Ltd. |
| 2025/03/10Import · Class 2.4 | 钇[90Y]微球注射液 · No verified English nameJXHL2500037 | Sirtex Medical Pty Ltd |
| 2025/03/10Generic · Class 3 | Sucralfate Oral SuspensionCYHS2500989 | Anhui Rui Qi Pharma Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized |
| 2025/03/10Generic · Class 3 | Aminophylline TabletsCYHS2500988 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.; Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized |
| 2025/03/10Generic · Class 3 | 奥泽沙星洗剂 · No verified English nameCYHL2500058 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2025/03/10New drug · Class 1 | XH001注射液 · No verified English nameCXSL2500215 | Beijing Xin He Rui En Bio Medical Technology Co., Ltd. romanized |
| 2025/03/09New drug · Class 1 | JMT106注射液 · No verified English nameCXSL2500214 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2025/03/08Import · Class 1 | BMS-986365胶囊 · No verified English nameJXHL2500036 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/03/08Generic · Class 3 | Buspirone Hydrochloride TabletsCYHS2500983 | Hebei Long Hai Pharma Co., Ltd. romanized |
| 2025/03/08Generic · Class 3 | 盐酸多沙普仑注射液 · No verified English nameCYHS2500976 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2025/03/08Generic · Class 3 | Propafenone Hydrochloride InjectionCYHS2500968 | Nan Yang Pu Kang Heng Wang Pharma Co., Ltd. romanized; Nan Yang Pu Kang Pharma Co., Ltd. romanized |
| 2025/03/08Generic · Class 3 | Isoprenaline Hydrochloride InjectionCYHS2500967 | Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized |
| 2025/03/08Generic · Class 3 | 维生素K滴剂 · No verified English nameCYHS2500965 | Sichuan Hai Meng Zhi Sen Biopharmaceutical Co., Ltd. romanized; Tianjin Shi Zhong Yang Pharma Co., Ltd. romanized |
| 2025/03/08Generic · Class 3 | Dobutamine Hydrochloride InjectionCYHS2500964 | Wuhan Shi Jin Heng Tai Pharma Co., Ltd. romanized; Henan Pu Rui Pharma Co., Ltd. romanized |
60 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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