YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 383 drug applications between 16 June 2026 and 22 June 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 49, covering 37 drug names.
2026/06/16 – 2026/06/22
- New acceptances this week
- 383
- Drugs with new generic filings (by drug name, de-duplicated)
- 37
- Accepted this week, now under review
- 101
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
383filings, 49 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 236 |
| New drug | 58 |
| Generic | 49 |
| Import | 20 |
| Unspecified | 10 |
| Import re-registration | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 168 |
| TCM | 144 |
| Therapeutic biologic | 62 |
| Prophylactic biologic | 6 |
| 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
37 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Nafamostat Mesilate for Injection | 4 | 2 | 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 | 环硅酸锆钠散 · No verified English name | 2 | 1 | 12 |
| 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 | Acetylcysteine Tablets | 1 | 1 | 8 |
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
227 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 | Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized | 8 | 8 | 0 |
| 3 | Novo Nordisk A/S | 8 | 2 | 0 |
| 4 | Heilongjiang Zhen Bao Dao Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized | 5 | 4 | 0 |
| 6 | Zhejiang Wo Wu Bio Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Shanxi Hua Kang Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Shanxi Jin Xin Shuang He 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
104 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/06/22Import · Class 2.4 | 甲苯磺酸他拉唑帕利胶囊 · No verified English nameJXHS2600071 | Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd. |
| 2026/06/22Import · Class 2.4 | 甲苯磺酸他拉唑帕利胶囊 · No verified English nameJXHS2600070 | Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd. |
| 2026/06/22Import · Class 2.4 | 甲苯磺酸他拉唑帕利胶囊 · No verified English nameJXHS2600069 | Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd. |
| 2026/06/22Import · Class 2.4 | 甲苯磺酸他拉唑帕利胶囊 · No verified English nameJXHS2600068 | Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd. |
| 2026/06/22Generic · Class 3 | Acetylcysteine TabletsCYHS2601460 | Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized |
| 2026/06/22Generic · Class 3 | Doxycycline Hyclate TabletsCYHS2601459 | Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized |
| 2026/06/22New drug · Class 3.1 | 清金化痰汤颗粒 · No verified English nameCXZS2600032 | Hunan Jiudian Pharmaceutical Co., Ltd |
| 2026/06/22New drug · Class 1 | 注射用LYNC-101 · No verified English nameCXSL2600660 | Ling Tai Tian Run Bio Technology (Shanghai) Co., Ltd. romanized |
| 2026/06/22New drug · Class 1 | TVAX-008注射液 · No verified English nameCXSL2600659 | Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Hangzhou) Co., Ltd. romanized |
| 2026/06/22New drug · Class 1.2 | 新型流感病毒mRNA疫苗 · No verified English nameCXSL2600658 | Hua Lan Bio Yi Miao Co., Ltd. romanized |
| 2026/06/22New drug · Class 1 | MT2004胶囊 · No verified English nameCXHL2600745 | Xian Ao Li Tai Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/06/22New drug · Class 1 | MT2004胶囊 · No verified English nameCXHL2600744 | Xian Ao Li Tai Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/06/22New drug · Class 1 | AHB-137注射液 · No verified English nameCXHL2600743 | Hangzhou Hao Bo Pharmaceuticals Co., Ltd. romanized |
| 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 |
74 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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