YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 359 drug applications between 15 June 2026 and 21 June 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 55, covering 42 drug names.
2026/06/15 – 2026/06/21
- New acceptances this week
- 359
- Drugs with new generic filings (by drug name, de-duplicated)
- 42
- Accepted this week, now under review
- 104
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
359filings, 55 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 211 |
| New drug | 57 |
| Generic | 55 |
| Import | 18 |
| Import re-registration | 11 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 172 |
| TCM | 125 |
| Therapeutic biologic | 54 |
| Prophylactic biologic | 5 |
| Biologic | 3 |
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
42 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Nafamostat Mesilate for Injection | 5 | 3 | 38 |
| 2 | Landiolol Hydrochloride for Injection | 3 | 3 | 19 |
| 3 | Propranolol hydrochloride oral solution | 2 | 2 | 4 |
| 4 | Emedastine Difumarate Sustained-release Capsules | 2 | 1 | 11 |
| 5 | Metoprolol Succinate Extended-release Capsules | 2 | 1 | 4 |
| 6 | Ioversol Injection | 2 | 1 | 9 |
| 7 | 苯磺酸左氨氯地平片 · No verified English name | 2 | 1 | 45 |
| 8 | Mirogabalin Besilate Tablets | 2 | 1 | 61 |
| 9 | Dapagliflozin Tablets | 2 | 1 | 84 |
| 10 | Upadacitinib Sustained-release Tablets | 1 | 1 | 43 |
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
205 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Zhong Mei Hua Yi (Hebei) Pharmaceutical Co., Ltd. romanized | 9 | 9 | 0 |
| 2 | Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized | 9 | 8 | 0 |
| 3 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 9 | 3 | 0 |
| 4 | Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized | 8 | 8 | 0 |
| 5 | Pfizer Inc. | 6 | 3 | 0 |
| 6 | Zhejiang Wo Wu Bio Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Shanxi Jin Xin Shuang He Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Heilongjiang Zhen Bao Dao Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Sichuan Sheng Tong Yuan Pharmaceutical Group Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Bristol-Myers Squibb Pharma EEIG | 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
103 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/06/18Import · Class 1 | BI 764532 输注用浓缩粉末 · No verified English nameJXSL2600146 | Boehringer lngelheim International GmbH; Boehringer lngelheim (China) Investment Co. Ltd. |
| 2026/06/18Generic · Class 3 | Nafamostat Mesilate for InjectionCYHS2601456 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Jilin Jin Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/06/18Generic · Class 3 | Nafamostat Mesilate for InjectionCYHS2601455 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Jilin Jin Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/06/18Generic · Class 3 | Emedastine Difumarate Sustained-release CapsulesCYHS2601452 | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized |
| 2026/06/18Generic · Class 3 | Emedastine Difumarate Sustained-release CapsulesCYHS2601451 | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized |
| 2026/06/18Generic · Class 3 | 对乙酰氨基酚甘露醇注射液 · No verified English nameCYHS2601450 | Guangzhou Nan Xin Pharmaceutical Co., Ltd. romanized; Dong Guan Shi Pu Ji Pharma Co., Ltd. romanized |
| 2026/06/18Generic · Class 3 | Propranolol hydrochloride oral solutionCYHS2601449 | Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized |
| 2026/06/18Generic · Class 3 | Ambroxol Hydrochloride DropsCYHS2601448 | Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized |
| 2026/06/18New drug · Class 1 | Pumitamig注射液 · No verified English nameCXSL2600657 | Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2026/06/18New drug · Class 1 | HEC-921注射液 · No verified English nameCXSL2600656 | Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized; Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2026/06/18New drug · Class 1 | YKYY033注射液 · No verified English nameCXHL2600742 | Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Tian Long Pharma Co., Ltd. romanized |
| 2026/06/18New drug · Class 1 | YKYY033注射液 · No verified English nameCXHL2600741 | Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Tian Long Pharma Co., Ltd. romanized |
| 2026/06/18New drug · Class 2.3 | TSL2402片 · No verified English nameCXHL2600740 | Tianjin Tian Shi Li Sheng Te Pharmaceutical Co., Ltd. romanized; Zhongguo Yao Ke University romanized |
| 2026/06/17Import · Class 1 | Lunsekimig注射液 · No verified English nameJXSL2600145 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2026/06/17Import · Class 1 | HDP-101 · No verified English nameJXSL2600144 | Heidelberg Pharma AG; Hangzhou Zhongmei HuaDong Pharmaceutical Co. Ltd. |
| 2026/06/17Import · Class 1 | ASP2138注射液 · No verified English nameJXSL2600143 | Astellas Pharma Global Development Inc.; Astellas (Beijing) Pharmaceutical R&D Co. Ltd. |
| 2026/06/17Generic · Class 3 | Succinylcholine Chloride InjectionCYHS2601444 | Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Wei Qi Da Guang Ming Pharmaceutical Co., Ltd. romanized |
| 2026/06/17Generic · Class 3 | Nafamostat Mesilate for InjectionCYHS2601443 | Hunan Fu Rui Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized |
| 2026/06/17Generic · Class 3 | Nafamostat Mesilate for InjectionCYHS2601442 | Hunan Fu Rui Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized |
| 2026/06/17Generic · Class 3 | Hydrotalcite SuspensionCYHS2601441 | Jilin Sheng Bo Cai Zhong Ke Biopharmaceuticals Co., Ltd. romanized; Jilin Sheng Bo Da Wei Ye Pharmaceutical Co., Ltd. romanized |
| 2026/06/17Generic · Class 3 | Methotrexate TabletsCYHS2601436 | Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Hainan Ri Zhong Tian Pharmaceutical Co., Ltd. romanized |
| 2026/06/17Generic · Class 3 | Landiolol Hydrochloride for InjectionCYHS2601435 | Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized |
| 2026/06/17Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2601434 | Wuhan Ren Fu Pharma Co., Ltd. romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2026/06/17Generic · Class 3 | Ferrous Succinate TabletsCYHS2601433 | Zhejiang He Li Xin Jian Pharma Co., Ltd. romanized |
| 2026/06/17Generic · Class 3 | 富马酸氯马斯汀口服溶液 · No verified English nameCYHS2601431 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2026/06/17Generic · Class 3 | Potassium Chloride Oral SolutionCYHS2601430 | Chongqing Xi Er An Pharma Co., Ltd. romanized; Chongqing Guo Tai Kang Ning Pharmaceutical Co., Ltd. romanized |
| 2026/06/17Generic · Class 3 | Fluocinolone Acetonide,Hydroquinone And Tretinoin CreamCYHL2600073 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2026/06/17Generic · Class 3 | 贝派度酸依折麦布片 · No verified English nameCYHL2600072 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD. |
| 2026/06/17New drug · Class 1 | 依达格鲁肽α注射液 · No verified English nameCXSS2600095 | Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized |
| 2026/06/17New drug · Class 1 | 依达格鲁肽α注射液 · No verified English nameCXSS2600094 | Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized |
73 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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