YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 481 drug applications between 30 October 2026 and 5 November 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 69, covering 51 drug names.
2026/10/30 – 2026/11/05
- New acceptances this week
- 481
- Drugs with new generic filings (by drug name, de-duplicated)
- 51
- Accepted this week, now under review
- 481
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
481filings, 69 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 237 |
| New drug | 108 |
| Generic | 69 |
| Import | 49 |
| Import re-registration | 16 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 241 |
| TCM | 146 |
| Therapeutic biologic | 86 |
| 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
51 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Piperacillin Sodium for Injection | 3 | 1 | 16 |
| 2 | Metformin Hydrochloride Extended-release Tablets | 3 | 1 | 10 |
| 3 | Emedastine Difumarate Eye Drops | 2 | 2 | 9 |
| 4 | 氟比洛芬凝胶贴膏 · No verified English name | 2 | 2 | 16 |
| 5 | 氧 · No verified English name | 2 | 2 | 15 |
| 6 | Mirogabalin Besilate Tablets | 2 | 2 | 61 |
| 7 | 蒙脱石混悬液 · No verified English name | 2 | 2 | 31 |
| 8 | Apalutamide Tablets | 2 | 2 | 18 |
| 9 | 复方氨基酸注射液(17AA-SF) · No verified English name | 2 | 1 | 4 |
| 10 | Dotinurad Tablets | 2 | 1 | 55 |
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
275 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Amgen Inc. | 12 | 3 | 0 |
| 2 | Eli Lilly and Company | 9 | 1 | 0 |
| 3 | Sichuan Xin Da Kang Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 4 | AstraZeneca AB | 7 | 4 | 0 |
| 5 | Fresenius Kabi AB | 7 | 2 | 0 |
| 6 | Hebei Wan Sui Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 6 | 6 | 0 |
| 8 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 6 | 3 | 0 |
| 9 | MUNDIPHARMA GmbH | 6 | 1 | 0 |
| 10 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 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
- 441
- Left the under-review list this week
- 511
Of these, NMPA published approval-document delivery for 280 (including 274 supplemental applications, not counted as new marketing approvals) and notification delivery for 22; the outcome of the other 209 is to be checked.
Most filings leaving review, by company
| # | Company (first applicant) | Filings | Drugs |
|---|---|---|---|
| 1 | Beijing Bao Shu Tang Technology Pharma Co., Ltd. romanized | 12 | 12 |
| 2 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 8 | 8 |
| 3 | AstraZeneca AB | 8 | 5 |
| 4 | Novo Nordisk A/S | 8 | 2 |
| 5 | Topfond Pharmaceutical Co., Ltd. | 6 | 6 |
| 6 | Jiao Zuo Fu Rui Tang Pharmaceutical Co., Ltd. romanized | 5 | 5 |
| 7 | Guangzhou Nuo Jin Pharmaceutical Co., Ltd. romanized | 5 | 4 |
| 8 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized | 5 | 2 |
| 9 | Shanghai Lei Yun Shang Pharma Co., Ltd. romanized | 4 | 4 |
| 10 | Shanxi Ao Er Pharma Co., Ltd. romanized | 4 | 4 |
Most filings entering review, by company
| # | Company (first applicant) | Filings | Drugs |
|---|---|---|---|
| 1 | Eli Lilly and Company | 9 | 1 |
| 2 | Sichuan Xin Da Kang Pharma Co., Ltd. romanized | 7 | 7 |
| 3 | AstraZeneca AB | 7 | 4 |
| 4 | Fresenius Kabi AB | 7 | 2 |
| 5 | Hebei Wan Sui Pharma Co., Ltd. romanized | 6 | 6 |
| 6 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 6 | 6 |
| 7 | MUNDIPHARMA GmbH | 6 | 1 |
| 8 | Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized | 6 | 1 |
| 9 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 |
| 10 | Amgen 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
177 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/11/05Import · Class 3.1 | 马塔西单抗注射液 · No verified English nameJXSS2600102 | Pfizer Inc.; Pfizer Manufacturing Belgium NV; Pfizer Investment Co. Ltd. |
| 2026/11/05Import · Class 1 | PAC001 注射液 · No verified English nameJXSL2600305 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/11/05Import · Class 1 | PAC001 注射液 · No verified English nameJXSL2600304 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/11/05Import · Class 2.2 | Panitumumab · No verified English nameJXSL2600303 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd. |
| 2026/11/05Import · Class 1 | AMG 410 · No verified English nameJXHL2600496 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd. |
| 2026/11/05Import · Class 1 | AMG 410 · No verified English nameJXHL2600495 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd. |
| 2026/11/05Import · Class 1 | AMG 410 · No verified English nameJXHL2600494 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd. |
| 2026/11/05Import · Class 1 | AMG 410 · No verified English nameJXHL2600493 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd. |
| 2026/11/05Import · Class 1 | AMG 410 · No verified English nameJXHL2600492 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd. |
| 2026/11/05Import · Class 1 | AMG 410 · No verified English nameJXHL2600491 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd. |
| 2026/11/05Import · Class 2.4 | Mavacamten胶囊 · No verified English nameJXHL2600490 | MyoKardia Inc.; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/11/05Import · Class 2.4 | Mavacamten胶囊 · No verified English nameJXHL2600489 | MyoKardia Inc.; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/11/05Import · Class 2.4 | Mavacamten胶囊 · No verified English nameJXHL2600488 | MyoKardia Inc.; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/11/05Import · Class 2.4 | Pemafibrate缓释片 · No verified English nameJXHL2600487 | Kowa Company Ltd.; Hangzhou Tigermed Consulting Co. Ltd. |
| 2026/11/05Import · Class 2.4 | Mavacamten胶囊 · No verified English nameJXHL2600486 | MyoKardia Inc.; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/11/05Import · Class 2.4 | Mavacamten胶囊 · No verified English nameJXHL2600485 | MyoKardia Inc.; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/11/05Generic · Class 3 | Indocyaninegreen for InjectionCYHS2602723 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2026/11/05Generic · Class 3 | Calcitriol Oral SolutionCYHS2602719 | Shijiazhuang Ke Ren Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/11/05Generic · Class 3 | Dexketoprofen Trometamol InjectionCYHS2602711 | Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2026/11/05Generic · Class 3 | Piperacillin Sodium for InjectionCYHS2602709 | Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized |
| 2026/11/05Generic · Class 3 | Piperacillin Sodium for InjectionCYHS2602708 | Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized |
| 2026/11/05Generic · Class 3 | Piperacillin Sodium for InjectionCYHS2602707 | Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized |
| 2026/11/05Generic · Class 3 | Oxaliplatin InjectionCYHS2602705 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2026/11/05Generic · Class 3 | Oxaliplatin InjectionCYHS2602703 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2026/11/05New drug · Class 3.4 | 人血白蛋白 · No verified English nameCXSS2600185 | Guangxi Lai Shi Biopharmaceutical Co., Ltd. romanized |
| 2026/11/05New drug · Class 1 | BJ047注射液(皮下注射) · No verified English nameCXSL2601233 | Shanghai Bao Ji Pharma Co., Ltd. romanized |
| 2026/11/05New drug · Class 3.4 | 静注人免疫球蛋白 · No verified English nameCXSL2601232 | Yuan Da Shu Yang Sheng Ming Ke Xue (Chengdu) Co., Ltd. romanized |
| 2026/11/05New drug · Class 1 | 注射用HMPL-A177 · No verified English nameCXSL2601231 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/11/05New drug · Class 1 | IBI3019 · No verified English nameCXSL2601230 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/11/05New drug · Class 1 | QLS2409注射液 · No verified English nameCXSL2601229 | Qilu Pharmaceutical Co., Ltd. |
147 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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