YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 366 drug applications between 7 November 2026 and 13 November 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 72, covering 43 drug names.
2026/11/07 – 2026/11/13
- New acceptances this week
- 366
- Drugs with new generic filings (by drug name, de-duplicated)
- 43
- Accepted this week, now under review
- 366
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
366filings, 72 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 181 |
| New drug | 74 |
| Generic | 72 |
| Import | 31 |
| Unspecified | 5 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 206 |
| TCM | 84 |
| Therapeutic biologic | 68 |
| Biologic | 4 |
| Unspecified | 2 |
| Prophylactic 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
43 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dotinurad Tablets | 4 | 2 | 55 |
| 2 | Ibuprofen Injection | 4 | 2 | 8 |
| 3 | Polyvinyl Alcohol Eye Drops | 3 | 2 | 24 |
| 4 | Brivaracetam Tablets | 3 | 1 | 19 |
| 5 | Fosfomycin Sodium For Injection | 3 | 1 | 16 |
| 6 | Mirogabalin Besilate Tablets | 3 | 1 | 61 |
| 7 | 西诺氨酯片 · No verified English name | 3 | 1 | 24 |
| 8 | Tafluprost Eye Drops | 2 | 2 | 3 |
| 9 | Ertugliflozin Tablets | 2 | 2 | 13 |
| 10 | Buprenorphine Hydrochloride and Naloxone Hydrochloride Sublingual Tablets | 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
228 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | F. Hoffmann-La Roche Ltd | 8 | 2 | 0 |
| 2 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 7 | 3 | 5 |
| 3 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 7 | 3 | 0 |
| 4 | CISEN PHARMACEUTICAL CO., LTD. | 6 | 3 | 3 |
| 5 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 6 | Suzhou Ya Sheng Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Chengdu Shuo De Pharma Co., Ltd. romanized | 5 | 3 | 1 |
| 9 | Novo Nordisk A/S | 5 | 1 | 0 |
| 10 | Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory romanized | 4 | 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
- Entered review this week
- 444
- Left the under-review list this week
- 292
Of these, NMPA published approval-document delivery for 48 (including 48 supplemental applications, not counted as new marketing approvals) and notification delivery for 5; the outcome of the other 239 is to be checked.
Most filings leaving review, by company
| # | Company (first applicant) | Filings | Drugs |
|---|---|---|---|
| 1 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 8 | 2 |
| 2 | Rui Li Shi Wan Ting Min Xin Pharmaceutical Co., Ltd. romanized | 7 | 1 |
| 3 | Sichuan Pharmaceutical Formulations Co., Ltd. romanized | 6 | 3 |
| 4 | Liaoning Min Kang Pharmaceutical Co., Ltd. romanized | 6 | 2 |
| 5 | Novo Nordisk A/S | 5 | 1 |
| 6 | Shanghai Kai Mao Biopharmaceuticals Co., Ltd. romanized | 5 | 1 |
| 7 | Merck Sharp & Dohme LLC | 4 | 3 |
| 8 | TIANJIN LISHENG PHARMACEUTICAL CO., LTD | 4 | 2 |
| 9 | NAPP PHARMACEUTICALS LIMITED | 4 | 1 |
| 10 | Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 3 | 3 |
Most filings entering review, by company
| # | Company (first applicant) | Filings | Drugs |
|---|---|---|---|
| 1 | F. Hoffmann-La Roche Ltd | 8 | 2 |
| 2 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 7 | 3 |
| 3 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 7 | 3 |
| 4 | CISEN PHARMACEUTICAL CO., LTD. | 6 | 3 |
| 5 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 6 | 1 |
| 6 | Suzhou Ya Sheng Pharma Co., Ltd. romanized | 6 | 1 |
| 7 | Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized | 5 | 5 |
| 8 | AstraZeneca AB | 5 | 3 |
| 9 | Chengdu Shuo De Pharma Co., Ltd. romanized | 5 | 3 |
| 10 | Pfizer Inc. | 5 | 2 |
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
124 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/11/12Import · Class 1 | MAR001 · No verified English nameJXSL2600314 | Marea Therapeutics Inc.; Beijing MEDPACE Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/11/12Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2602792 | Guangdong Nan Guo Pharma Co., Ltd. romanized |
| 2026/11/12Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2602791 | Guangdong Nan Guo Pharma Co., Ltd. romanized |
| 2026/11/12Generic · Class 3 | 6-[18F]Fluoro-L-DOPA InjectionCYHS2602790 | Jiangsu Hua Yi He Pharmaceuticals Co., Ltd. romanized |
| 2026/11/12Generic · Class 3 | Hydrocortisone TabletsCYHS2602788 | Da Wei (Anhui) Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2026/11/12Generic · Class 3 | Hydrocortisone TabletsCYHS2602786 | Da Wei (Anhui) Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2026/11/12Generic · Class 3 | Bilastine Oral SolutionCYHS2602781 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2026/11/12New drug · Class 1 | IBI354 · No verified English nameCXSL2601263 | Xin Da Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized |
| 2026/11/12New drug · Class 1 | EDP004注射液 · No verified English nameCXSL2601262 | Yi Teng Pharmaceuticals (Zhuhai) Co., Ltd. romanized |
| 2026/11/12New drug · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameCXSL2601261 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2026/11/12New drug · Class 1 | 注射用VRT106 · No verified English nameCXSL2601260 | Guangzhou Wei Rong Te Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/11/12New drug · Class 1 | YSC001注射液 · No verified English nameCXSL2601259 | Yan Sheng Chao (Beijing) Bio Technology Co., Ltd. romanized |
| 2026/11/12New drug · Class 2.2 | 三价流感病毒裂解疫苗(MDCK 细胞) · No verified English nameCXSL2601258 | Guangzhou Shi Jia He Bio Technology Co., Ltd. romanized |
| 2026/11/12New drug · Class 1 | 注射用依康坦博妥塔单抗 · No verified English nameCXSL2601257 | Luo Shi (Zhongguo) Investment Co., Ltd. romanized |
| 2026/11/12New drug · Class 1 | 注射用奥丁安妥拜单抗 · No verified English nameCXSL2601256 | Zhejiang Xin Ma Biopharmaceuticals Co., Ltd. romanized |
| 2026/11/12New drug · Class 1 | GR2304注射液(皮下注射) · No verified English nameCXSL2601255 | Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized |
| 2026/11/12New drug · Class 1 | 注射用BAT8013 · No verified English nameCXSL2601254 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2026/11/12New drug · Class Unmapped source value | CZ025 · No verified English nameCXHL2601424 | Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized |
| 2026/11/12New drug · Class Unmapped source value | CZ025 · No verified English nameCXHL2601423 | Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized |
| 2026/11/12New drug · Class 1 | RO7673396薄膜包衣片 · No verified English nameCXHL2601422 | Luo Shi Research and Development (Zhongguo) Co., Ltd. romanized |
| 2026/11/12New drug · Class 1 | RO7673396薄膜包衣片 · No verified English nameCXHL2601421 | Luo Shi Research and Development (Zhongguo) Co., Ltd. romanized |
| 2026/11/12New drug · Class 1 | ACT001胶囊 · No verified English nameCXHL2601420 | Xin Yi Shang De Yao Yuan Pharma Co., Ltd. romanized |
| 2026/11/12New drug · Class Unmapped source value | 枸橼酸坦度螺酮缓释片 · No verified English nameCXHL2601419 | Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized |
| 2026/11/12New drug · Class Unmapped source value | 枸橼酸坦度螺酮缓释片 · No verified English nameCXHL2601418 | Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized |
| 2026/11/12New drug · Class 2.2 | 枸橼酸坦度螺酮缓释片 · No verified English nameCXHL2601417 | Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized |
| 2026/11/12New drug · Class 2.2 | 枸橼酸坦度螺酮缓释片 · No verified English nameCXHL2601416 | Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized |
| 2026/11/12New drug · Class 1 | APG-3288片 · No verified English nameCXHL2601415 | Suzhou Ya Sheng Pharma Co., Ltd. romanized |
| 2026/11/12New drug · Class 1 | APG-3288片 · No verified English nameCXHL2601414 | Suzhou Ya Sheng Pharma Co., Ltd. romanized |
| 2026/11/12New drug · Class 1 | APG-3288片 · No verified English nameCXHL2601413 | Suzhou Ya Sheng Pharma Co., Ltd. romanized |
| 2026/11/12New drug · Class Unmapped source value | CYH33干混悬剂 · No verified English nameCXHL2601412 | Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized |
94 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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