YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 475 drug applications between 4 November 2026 and 10 November 2026 (data as of 14 November 2026 06:00). Of these, generic applications numbered 81, covering 52 drug names.
2026/11/04 – 2026/11/10
- New acceptances this week
- 475
- Drugs with new generic filings (by drug name, de-duplicated)
- 52
- Accepted this week, now under review
- 475
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
475filings, 81 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 252 |
| Generic | 81 |
| New drug | 77 |
| Import | 54 |
| Import re-registration | 10 |
| Unspecified | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 259 |
| TCM | 112 |
| Therapeutic biologic | 95 |
| 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
52 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 | Mirogabalin Besilate Tablets | 4 | 2 | 61 |
| 3 | Ertugliflozin Tablets | 3 | 3 | 13 |
| 4 | Polyvinyl Alcohol Eye Drops | 3 | 2 | 24 |
| 5 | Brivaracetam Tablets | 3 | 1 | 19 |
| 6 | Piperacillin Sodium for Injection | 3 | 1 | 16 |
| 7 | Metformin Hydrochloride Extended-release Tablets | 3 | 1 | 10 |
| 8 | Edaravone and Dexborneol Concentrated Solution for Injection | 2 | 2 | 34 |
| 9 | Cetylpyridinium Chloride Buccal Tablets | 2 | 2 | 5 |
| 10 | Oxaliplatin Injection | 2 | 1 | 4 |
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
287 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Amgen Inc. | 12 | 3 | 0 |
| 2 | Novo Nordisk A/S | 10 | 1 | 0 |
| 3 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 6 | 5 | 0 |
| 4 | Pfizer Inc. | 6 | 3 | 0 |
| 5 | F. Hoffmann-La Roche Ltd | 6 | 1 | 0 |
| 6 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | AstraZeneca AB | 5 | 3 | 0 |
| 8 | Chengdu Shuo De Pharma Co., Ltd. romanized | 5 | 3 | 1 |
| 9 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 5 | 2 | 3 |
| 10 | MyoKardia Inc. | 5 | 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
- Entered review this week
- 485
- Left the under-review list this week
- 515
Of these, NMPA published approval-document delivery for 279 (including 264 supplemental applications, not counted as new marketing approvals) and notification delivery for 17; the outcome of the other 219 is to be checked.
Most filings leaving review, by company
| # | Company (first applicant) | Filings | Drugs |
|---|---|---|---|
| 1 | AstraZeneca AB | 6 | 4 |
| 2 | Liaoning Min Kang Pharmaceutical Co., Ltd. romanized | 6 | 2 |
| 3 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 5 | 5 |
| 4 | Guangzhou Nuo Jin Pharmaceutical Co., Ltd. romanized | 5 | 4 |
| 5 | Novo Nordisk A/S | 5 | 1 |
| 6 | Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 4 | 4 |
| 7 | Sichuan Tai Le Pharmaceutical Co., Ltd. romanized | 4 | 4 |
| 8 | Hubei Dong Xin Pharma Co., Ltd. romanized | 4 | 4 |
| 9 | Jiangxi Shimei Pharmaceutical Co., Ltd | 4 | 2 |
| 10 | Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized | 4 | 2 |
Most filings entering review, by company
| # | Company (first applicant) | Filings | Drugs |
|---|---|---|---|
| 1 | Amgen Inc. | 12 | 3 |
| 2 | AstraZeneca AB | 10 | 5 |
| 3 | Sichuan Xin Da Kang Pharma Co., Ltd. romanized | 7 | 7 |
| 4 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 6 | 5 |
| 5 | Pfizer Inc. | 6 | 3 |
| 6 | MyoKardia Inc. | 5 | 1 |
| 7 | Novo Nordisk A/S | 5 | 1 |
| 8 | Shenzhen Shi Tian Dao Pharmaceuticals Co., Ltd. romanized | 5 | 1 |
| 9 | Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized | 5 | 1 |
| 10 | Xiamen Zhong Pharmaceutical Factory Co., Ltd. romanized | 4 | 4 |
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
153 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/11/10Import · Class 1 | 卡瑞林肽司美格鲁肽注射液 · No verified English nameJXSS2600109 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2026/11/10Import · Class 1 | 卡瑞林肽司美格鲁肽注射液 · No verified English nameJXSS2600108 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2026/11/10Import · Class 1 | 卡瑞林肽司美格鲁肽注射液 · No verified English nameJXSS2600107 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2026/11/10Import · Class 1 | 卡瑞林肽司美格鲁肽注射液 · No verified English nameJXSS2600106 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2026/11/10Import · Class 1 | 卡瑞林肽司美格鲁肽注射液 · No verified English nameJXSS2600105 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2026/11/10Import · Class 1 | GSK3862995B注射液 · No verified English nameJXSL2600310 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Company Limited |
| 2026/11/10Import · Class 1 | RO7795068注射液 · No verified English nameJXHL2600505 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/11/10Import · Class 1 | RO7795068注射液 · No verified English nameJXHL2600504 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/11/10Import · Class 1 | RO7795068注射液 · No verified English nameJXHL2600503 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/11/10Import · Class 1 | RO7795068注射液 · No verified English nameJXHL2600502 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/11/10Import · Class 1 | RO7795068注射液 · No verified English nameJXHL2600501 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/11/10Import · Class 1 | RO7795068注射液 · No verified English nameJXHL2600500 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/11/10Generic · Class 3 | Cetylpyridinium Chloride Buccal TabletsCYHS2602766 | Zhejiang Yi Han Pharmaceutical Co., Ltd. romanized |
| 2026/11/10Generic · Class 3 | Calcium Carbonate TabletsCYHS2602759 | Beijing Xin Mei Tai Ke Pharmaceuticals Technology Co., Ltd. romanized; Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized |
| 2026/11/10New drug · Class 1 | BR1A101注射液 · No verified English nameCXSL2601251 | Zhong Ke Bai Rui (Changchun) Bio Technology Co., Ltd. romanized |
| 2026/11/10New drug · Class 1 | 注射用DR510 · No verified English nameCXSL2601250 | Zhejiang Dao Er Bio Technology Co., Ltd. romanized |
| 2026/11/10New drug · Class 1 | GSK5784283注射液 · No verified English nameCXSL2601249 | Ge Lan Su Shi Ke (Zhongguo) Investment Co., Ltd. romanized |
| 2026/11/10New drug · Class 1 | PRBT001注射液 · No verified English nameCXSL2601248 | Pan Ru Bio Technology (Tianjin) Co., Ltd. romanized |
| 2026/11/10New drug · Class 1 | Zoldonrasib片 · No verified English nameCXHL2601391 | Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized |
| 2026/11/10New drug · Class 2.2 | BCM1139 · No verified English nameCXHL2601390 | Hubei Mei Lin Pharma Co., Ltd. romanized |
| 2026/11/10New drug · Class 2.4 | Glycopyrrolate InjectionCXHL2601389 | Guangdong Jia Bo Pharmaceutical Co., Ltd. romanized |
| 2026/11/10New drug · Class 2.2 | EP-0330SP · No verified English nameCXHL2601388 | Chengdu Shuo De Pharma Co., Ltd. romanized |
| 2026/11/10New drug · Class 2.2 | EP-0330SP · No verified English nameCXHL2601387 | Chengdu Shuo De Pharma Co., Ltd. romanized |
| 2026/11/10New drug · Class 2.2 | EP-0330SP · No verified English nameCXHL2601386 | Chengdu Shuo De Pharma Co., Ltd. romanized |
| 2026/11/09Import · Class 2.2 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600104 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd. |
| 2026/11/09Import · Class 2.2 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600103 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd. |
| 2026/11/09Import · Class 1 | AZD0299 · No verified English nameJXSL2600309 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd |
| 2026/11/09Import · Class 2.2 | 艾加莫德α注射液(皮下注射) · No verified English nameJXSL2600308 | argenx BV; Zai Lab (Shanghai) Co. Ltd. |
| 2026/11/09Import · Class 1 | BI 3822971 注射液 · No verified English nameJXSL2600307 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd |
| 2026/11/09Import · Class 1 | Efruxifermin注射用冻干粉 · No verified English nameJXSL2600306 | Akero Therapeutics Inc.; ICON Clinical Research (Beijing No. 2) Co. Ltd. |
123 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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