YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 440 drug applications between 9 November 2026 and 15 November 2026 (data as of 15 November 2026 06:00). Of these, generic applications numbered 81, covering 50 drug names.
2026/11/09 – 2026/11/15
- New acceptances this week
- 440
- Drugs with new generic filings (by drug name, de-duplicated)
- 50
- Accepted this week, now under review
- 440
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
440filings, 81 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 217 |
| New drug | 94 |
| Generic | 81 |
| Import | 38 |
| Unspecified | 5 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 241 |
| TCM | 106 |
| Therapeutic biologic | 80 |
| Prophylactic biologic | 6 |
| Biologic | 5 |
| Unspecified | 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
50 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 | Atropine Sulfate Injection | 4 | 2 | 5 |
| 4 | Polyvinyl Alcohol Eye Drops | 3 | 2 | 24 |
| 5 | Brivaracetam Tablets | 3 | 1 | 19 |
| 6 | Fosfomycin Sodium For Injection | 3 | 1 | 16 |
| 7 | Mirogabalin Besilate Tablets | 3 | 1 | 61 |
| 8 | 西诺氨酯片 · No verified English name | 3 | 1 | 24 |
| 9 | Tafluprost Eye Drops | 2 | 2 | 3 |
| 10 | Ertugliflozin Tablets | 2 | 2 | 13 |
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
268 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory romanized | 8 | 4 | 0 |
| 2 | F. Hoffmann-La Roche Ltd | 8 | 2 | 0 |
| 3 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 7 | 3 | 5 |
| 4 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 7 | 3 | 0 |
| 5 | CISEN PHARMACEUTICAL CO., LTD. | 6 | 3 | 3 |
| 6 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Suzhou Ya Sheng Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 8 | Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Chengdu Shuo De Pharma Co., Ltd. romanized | 5 | 3 | 1 |
| 10 | Eli Lilly and Company | 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
- Entered review this week
- 440
- Left the under-review list this week
- 471
Of these, NMPA published approval-document delivery for 153 (including 149 supplemental applications, not counted as new marketing approvals) and notification delivery for 9; the outcome of the other 309 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 | AbbVie Inc. | 8 | 1 |
| 3 | Rui Li Shi Wan Ting Min Xin Pharmaceutical Co., Ltd. romanized | 7 | 1 |
| 4 | Sichuan Pharmaceutical Formulations Co., Ltd. romanized | 6 | 3 |
| 5 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 6 | 2 |
| 6 | Liaoning Min Kang Pharmaceutical Co., Ltd. romanized | 6 | 2 |
| 7 | Merck Sharp & Dohme LLC | 5 | 4 |
| 8 | Novartis Pharma AG | 5 | 4 |
| 9 | Novo Nordisk A/S | 5 | 1 |
| 10 | Shanghai Kai Mao Biopharmaceuticals Co., Ltd. romanized | 5 | 1 |
Most filings entering review, by company
| # | Company (first applicant) | Filings | Drugs |
|---|---|---|---|
| 1 | Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory romanized | 8 | 4 |
| 2 | F. Hoffmann-La Roche Ltd | 8 | 2 |
| 3 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 7 | 3 |
| 4 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 7 | 3 |
| 5 | CISEN PHARMACEUTICAL CO., LTD. | 6 | 3 |
| 6 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 6 | 1 |
| 7 | Suzhou Ya Sheng Pharma Co., Ltd. romanized | 6 | 1 |
| 8 | Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized | 5 | 5 |
| 9 | Chengdu Shuo De Pharma Co., Ltd. romanized | 5 | 3 |
| 10 | Eli Lilly and Company | 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
152 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/11/13Import · Class 1 | 4D-150玻璃体内注射液 · No verified English nameJXSL2600315 | 4D Molecular Therapeutics Inc.; Fortrea Pharmaceutical Research and Development (Beijing) Co. Ltd. |
| 2026/11/13Import · Class 1 | Eloralintide注射液 · No verified English nameJXHL2600510 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/11/13Import · Class 1 | Eloralintide注射液 · No verified English nameJXHL2600509 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/11/13Import · Class 1 | Eloralintide注射液 · No verified English nameJXHL2600508 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/11/13Import · Class 1 | Eloralintide注射液 · No verified English nameJXHL2600507 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/11/13Generic · Class 3 | 琥珀酸亚铁散剂 · No verified English nameCYHS2602808 | Jin Ling Pharma Co., Ltd. Nanjing Jin Ling Pharmaceutical Factory romanized |
| 2026/11/13Generic · Class 3 | Atropine Sulfate InjectionCYHS2602807 | Jiangsu Fu Bang Pharma Co., Ltd. romanized |
| 2026/11/13Generic · Class 3 | Atropine Sulfate InjectionCYHS2602806 | Jiangsu Fu Bang Pharma Co., Ltd. romanized |
| 2026/11/13New drug · Class 2.4 | 注射用重组A型肉毒毒素(150 kD) · No verified English nameCXSS2600187 | Jun He Meng Biopharmaceutical (Tong Hua) Co., Ltd. romanized |
| 2026/11/13New drug · Class 1 | 重组人胸腺素β4滴眼液 · No verified English nameCXSL2601273 | Qing Cheng Xin Yao Bio Technology (Qingdao) Co., Ltd. romanized |
| 2026/11/13New drug · Class 1 | 重组人胸腺素β4滴眼液 · No verified English nameCXSL2601272 | Qing Cheng Xin Yao Bio Technology (Qingdao) Co., Ltd. romanized |
| 2026/11/13New drug · Class 1 | 重组人胸腺素β4滴眼液 · No verified English nameCXSL2601271 | Qing Cheng Xin Yao Bio Technology (Qingdao) Co., Ltd. romanized |
| 2026/11/13New drug · Class 1 | AK135注射液 · No verified English nameCXSL2601270 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2026/11/13New drug · Class 1 | MS8031注射液 · No verified English nameCXSL2601269 | Ningbo Mei Sai Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/11/13New drug · Class Unmapped source value | 冻干重组呼吸道合胞病毒蛋白疫苗(CHO细胞) · No verified English nameCXSL2601268 | Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized |
| 2026/11/13New drug · Class Unmapped source value | 冻干重组呼吸道合胞病毒蛋白疫苗(CHO细胞) · No verified English nameCXSL2601267 | Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized |
| 2026/11/13New drug · Class Unmapped source value | 冻干重组呼吸道合胞病毒蛋白疫苗(CHO细胞) · No verified English nameCXSL2601266 | Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized |
| 2026/11/13New drug · Class Unmapped source value | 度普利尤单抗注射液 · No verified English nameCXSL2601265 | Shanghai Hong Cheng Pharma Co., Ltd. romanized |
| 2026/11/13New drug · Class 1 | SKB575(HBM7575)注射液 · No verified English nameCXSL2601264 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized; He Bo Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/11/13New drug · Class 1 | HW060015胶囊 · No verified English nameCXHL2601433 | Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized |
| 2026/11/13New drug · Class 1 | HW060015胶囊 · No verified English nameCXHL2601432 | Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized |
| 2026/11/13New drug · Class 1 | LG-1057片 · No verified English nameCXHL2601431 | Lin Gang Guo Jia Laboratory romanized |
| 2026/11/13New drug · Class 1 | LG-1057片 · No verified English nameCXHL2601430 | Lin Gang Guo Jia Laboratory romanized |
| 2026/11/13New drug · Class 1 | LG-1057片 · No verified English nameCXHL2601429 | Lin Gang Guo Jia Laboratory romanized |
| 2026/11/13New drug · Class 1 | KR25102片 · No verified English nameCXHL2601428 | Jiangxi Ke Rui Pharma Co., Ltd. romanized |
| 2026/11/13New drug · Class 1 | CS231295片 · No verified English nameCXHL2601427 | Shenzhen Wei Xin Pharma Co., Ltd. romanized; Shenzhen Wei Xin Bio Technology Co., Ltd. romanized |
| 2026/11/13New drug · Class 1 | CS231295片 · No verified English nameCXHL2601426 | Shenzhen Wei Xin Pharma Co., Ltd. romanized; Shenzhen Wei Xin Bio Technology Co., Ltd. romanized |
| 2026/11/13New drug · Class 1 | CS231295片 · No verified English nameCXHL2601425 | Shenzhen Wei Xin Pharma Co., Ltd. romanized; Shenzhen Wei Xin Bio Technology Co., Ltd. romanized |
| 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 |
122 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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