YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 484 drug applications between 3 November 2026 and 9 November 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 81, covering 55 drug names.
2026/11/03 – 2026/11/09
- New acceptances this week
- 484
- Drugs with new generic filings (by drug name, de-duplicated)
- 55
- Accepted this week, now under review
- 484
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
484filings, 81 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 246 |
| New drug | 94 |
| Generic | 81 |
| Import | 47 |
| Import re-registration | 15 |
| Unspecified | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 247 |
| TCM | 125 |
| Therapeutic biologic | 103 |
| 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
55 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Mirogabalin Besilate Tablets | 4 | 2 | 61 |
| 2 | Ertugliflozin Tablets | 3 | 3 | 13 |
| 3 | Polyvinyl Alcohol Eye Drops | 3 | 2 | 24 |
| 4 | Brivaracetam Tablets | 3 | 1 | 19 |
| 5 | Piperacillin Sodium for Injection | 3 | 1 | 16 |
| 6 | Metformin Hydrochloride Extended-release Tablets | 3 | 1 | 10 |
| 7 | Edaravone and Dexborneol Concentrated Solution for Injection | 2 | 2 | 34 |
| 8 | Dotinurad Tablets | 2 | 1 | 55 |
| 9 | Oxaliplatin Injection | 2 | 1 | 4 |
| 10 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
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
294 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Amgen Inc. | 12 | 3 | 0 |
| 2 | AstraZeneca AB | 10 | 5 | 0 |
| 3 | Sichuan Xin Da Kang Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 4 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 6 | 5 | 0 |
| 5 | Pfizer Inc. | 6 | 3 | 0 |
| 6 | MyoKardia Inc. | 5 | 1 | 0 |
| 7 | Novo Nordisk A/S | 5 | 1 | 0 |
| 8 | Shenzhen Shi Tian Dao Pharmaceuticals Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Xiamen Zhong Pharmaceutical Factory Co., Ltd. romanized | 4 | 4 | 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
- 492
- Left the under-review list this week
- 574
Of these, NMPA published approval-document delivery for 350 (including 335 supplemental applications, not counted as new marketing approvals) and notification delivery for 20; the outcome of the other 204 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 | 10 | 10 |
| 2 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 8 | 8 |
| 3 | Topfond Pharmaceutical Co., Ltd. | 6 | 6 |
| 4 | Hubei Dong Xin Pharma Co., Ltd. romanized | 6 | 6 |
| 5 | Guangzhou Nuo Jin Pharmaceutical Co., Ltd. romanized | 6 | 5 |
| 6 | AstraZeneca AB | 6 | 4 |
| 7 | Jiao Zuo Fu Rui Tang Pharmaceutical Co., Ltd. romanized | 5 | 5 |
| 8 | Novo Nordisk A/S | 5 | 1 |
| 9 | Shanghai Lei Yun Shang Pharma Co., Ltd. romanized | 4 | 4 |
| 10 | Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 4 | 4 |
Most filings entering review, by company
| # | Company (first applicant) | Filings | Drugs |
|---|---|---|---|
| 1 | Amgen Inc. | 12 | 3 |
| 2 | AstraZeneca AB | 9 | 4 |
| 3 | Sichuan Xin Da Kang Pharma Co., Ltd. romanized | 7 | 7 |
| 4 | Pfizer Inc. | 7 | 4 |
| 5 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 7 | 4 |
| 6 | Hebei Wan Sui Pharma Co., Ltd. romanized | 6 | 6 |
| 7 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 6 | 6 |
| 8 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 |
| 9 | MyoKardia Inc. | 5 | 1 |
| 10 | Novo Nordisk A/S | 5 | 1 |
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
165 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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. |
| 2026/11/09Import · Class 2.4 | 艾曲帕米鼻喷雾剂 · No verified English nameJXHL2600498 | Milestone Pharmaceuticals Inc.; Everest Medicines (China) Co. Ltd. |
| 2026/11/09Import · Class 2.4 | 盐酸索安非托片 · No verified English nameJXHL2600497 | AXSOME MALTA LTD.; Ignis Therapeutics (Suzhou) Limited |
| 2026/11/09Generic · Class 3 | Atropine Sulfate InjectionCYHS2602756 | Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/11/09Generic · Class 3 | Atropine Sulfate InjectionCYHS2602755 | Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/11/09Generic · Class 3 | Ibuprofen InjectionCYHS2602751 | Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized |
| 2026/11/09Generic · Class 3 | Ibuprofen InjectionCYHS2602750 | Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized |
| 2026/11/09Generic · Class 3 | 布美他尼片 · No verified English nameCYHS2602749 | Zhejiang Hao Ge Pharma Co., Ltd. romanized |
| 2026/11/09Generic · Class 3 | Brivaracetam Oral SolutionCYHS2602747 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
| 2026/11/09Generic · Class 3 | Brivaracetam TabletsCYHS2602745 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2026/11/09Generic · Class 3 | Brivaracetam TabletsCYHS2602744 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2026/11/09Generic · Class 3 | Brivaracetam TabletsCYHS2602743 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2026/11/09Generic · Class 3 | 磷酸奥司他韦颗粒 · No verified English nameCYHS2602733 | Hunan Wei Te Pharmaceutical Co., Ltd. romanized |
| 2026/11/09New drug · Class 1 | 注射用BG-T0920 · No verified English nameCXSL2601247 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2026/11/09New drug · Class 1 | KT501注射液 · No verified English nameCXSL2601246 | Kai Lin Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/11/09New drug · Class 1 | 注射用CS5006 · No verified English nameCXSL2601245 | Ji Shi Pharma (Suzhou) Co., Ltd. romanized |
| 2026/11/09New drug · Class 1 | 注射用BCT-001 · No verified English nameCXSL2601244 | Shanghai Ba Kang Lian Yao Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/11/09New drug · Class 1 | SR604注射液 · No verified English nameCXSL2601243 | Shanghai Lai Shi Xue Ye Zhi Pin Co., Ltd. romanized |
| 2026/11/09New drug · Class 2.2 | 贝伐珠单抗注射液 · No verified English nameCXSL2601242 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/11/09New drug · Class 2.2 | 贝伐珠单抗注射液 · No verified English nameCXSL2601241 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/11/09New drug · Class 2.2 | 信迪利单抗注射液 · No verified English nameCXSL2601240 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/11/09New drug · Class 1 | IL17A纳米抗体基因修饰干细胞注射液 · No verified English nameCXSL2601239 | Beijing Bei Lai Bio Technology Co., Ltd. romanized |
| 2026/11/09New drug · Class 2.3 | EP-0170T(Ⅰ) · No verified English nameCXHS2600152 | Chengdu Shuo De Pharma Co., Ltd. romanized |
| 2026/11/09New drug · Class 2.4 | 单唾液酸四己糖神经节苷脂钠注射液 · No verified English nameCXHS2600151 | Qilu Pharmaceutical Co., Ltd. |
| 2026/11/09New drug · Class 2.4 | 单唾液酸四己糖神经节苷脂钠注射液 · No verified English nameCXHS2600150 | Qilu Pharmaceutical Co., Ltd. |
135 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.