YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 508 drug applications between 10 June 2026 and 16 June 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 80, covering 57 drug names.
2026/06/10 – 2026/06/16
- New acceptances this week
- 508
- Drugs with new generic filings (by drug name, de-duplicated)
- 57
- Accepted this week, now under review
- 142
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
508filings, 80 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 304 |
| Generic | 80 |
| New drug | 79 |
| Import | 26 |
| Import re-registration | 12 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 272 |
| TCM | 166 |
| Therapeutic biologic | 65 |
| Prophylactic biologic | 3 |
| Biologic | 2 |
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
57 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 | Mirogabalin Besilate Tablets | 5 | 2 | 61 |
| 3 | Landiolol Hydrochloride for Injection | 3 | 3 | 19 |
| 4 | 西诺氨酯片 · No verified English name | 3 | 1 | 24 |
| 5 | Upadacitinib Sustained-release Tablets | 2 | 2 | 43 |
| 6 | Brexpiprazole Tablets | 2 | 1 | 31 |
| 7 | Bumetanide Injection | 2 | 1 | 13 |
| 8 | 帕拉米韦氯化钠注射液 · No verified English name | 2 | 1 | 17 |
| 9 | Triamcinolone Acetonide and Econazole Nitrate Cream | 2 | 1 | 3 |
| 10 | 氨基酸(15)腹膜透析液 · No verified English name | 2 | 1 | 3 |
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
298 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized | 10 | 9 | 0 |
| 2 | Eli Lilly and Company | 8 | 3 | 0 |
| 3 | Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized | 7 | 7 | 0 |
| 4 | Pfizer Inc. | 6 | 3 | 0 |
| 5 | Amgen Inc. | 6 | 1 | 0 |
| 6 | Bao Tou Zhong Yao Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Hua Run Shuang He Xiang Zhong Pharma (Hunan) Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 5 | 2 | 0 |
| 9 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 5 | 2 | 0 |
| 10 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 5 | 2 | 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
138 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/06/16Import · Class 3.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600053 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D(China)Co. Ltd |
| 2026/06/16Import · Class 3.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600052 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D(China)Co. Ltd |
| 2026/06/16Import · Class 1 | BI 764532 输注用浓缩粉末 · No verified English nameJXSL2600142 | Boehringer lngelheim International GmbH; Boehringer lngelheim (China) Investment Co. Ltd. |
| 2026/06/16Import · Class 1 | Mezigdomide胶囊 · No verified English nameJXHS2600065 | Bristol-Myers Squibb Pharma EEIG; Celgene International Sarl; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/06/16Import · Class 1 | Mezigdomide胶囊 · No verified English nameJXHS2600064 | Bristol-Myers Squibb Pharma EEIG; Celgene International Sarl; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/06/16Import · Class 1 | Mezigdomide胶囊 · No verified English nameJXHS2600063 | Bristol-Myers Squibb Pharma EEIG; Celgene International Sarl; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/06/16Import · Class 1 | Mezigdomide胶囊 · No verified English nameJXHS2600062 | Bristol-Myers Squibb Pharma EEIG; Celgene International Sarl; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/06/16Import · Class 2.4 | 那米司特片 · No verified English nameJXHL2600221 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2026/06/16Import · Class 2.4 | 那米司特片 · No verified English nameJXHL2600220 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2026/06/16Import · Class 1 | YMI024 · No verified English nameJXHL2600219 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/06/16Generic · Class 3 | Propranolol hydrochloride oral solutionCYHS2601427 | Da Wei (Anhui) Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized |
| 2026/06/16Generic · Class 3 | 乳酸维持液含葡萄糖10% · No verified English nameCYHS2601426 | Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Dong Guan Shi Pu Ji Pharma Co., Ltd. romanized |
| 2026/06/16Generic · Class 3 | 复方聚乙二醇(3350)电解质维C散 · No verified English nameCYHS2601425 | Beijing Sheng Yong Pharmaceutical Co., Ltd. romanized |
| 2026/06/16Generic · Class 3 | Landiolol Hydrochloride for InjectionCYHS2601423 | NORTH CHINA PHARMACEUTICAL COMPANY.LTD |
| 2026/06/16Generic · Class 3 | Landiolol Hydrochloride for InjectionCYHS2601421 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2026/06/16Generic · Class 3 | Compound Paracetamol and Vitamin C Effervescent TabletsCYHS2601420 | Zhejiang He Li Xin Jian Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2026/06/16Generic · Class 3 | Magnesium Sulfate InjectionCYHS2601419 | Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd. |
| 2026/06/16New drug · Class 1 | 注射用ZL-1310 · No verified English nameCXSL2600645 | Zai Ding Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/06/16New drug · Class 1 | 注射用ZL-1310 · No verified English nameCXSL2600644 | Zai Ding Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/06/16New drug · Class 1.2 | 重组轮状病毒亚单位疫苗(大肠杆菌) · No verified English nameCXSL2600643 | Beijing Zhi Fei Lv Zhu Biopharmaceutical Co., Ltd. romanized |
| 2026/06/16New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2600642 | Shenzhen Shi Yin Guan Bio Technology Co., Ltd. romanized |
| 2026/06/16New drug · Class 1 | SCTB41注射液 · No verified English nameCXSL2600641 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2026/06/16New drug · Class 1 | 注射用YL242 · No verified English nameCXSL2600640 | Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized |
| 2026/06/16New drug · Class 1 | 注射用聚乙二醇化促血小板生成肽 · No verified English nameCXSL2600639 | Chongqing Pai Jin Bio Technology Co., Ltd. romanized |
| 2026/06/16New drug · Class 2.3 | 缬沙坦马来酸左氨氯地平片 · No verified English nameCXHS2600090 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2026/06/16New drug · Class 1 | 镥[177Lu]JH020002注射液 · No verified English nameCXHL2600726 | Jing He Biopharmaceuticals (Shanghai) Co., Ltd. romanized; Jing He Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/06/16New drug · Class 1 | GFH276片 · No verified English nameCXHL2600725 | Jin Fang Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/06/16New drug · Class 2.1; 2.4 | SAL0120CSA片 · No verified English nameCXHL2600724 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2026/06/16New drug · Class 2.1; 2.4 | SAL0120CSA片 · No verified English nameCXHL2600723 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2026/06/16New drug · Class 2.1; 2.4 | SAL0120CSA片 · No verified English nameCXHL2600722 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
108 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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