YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 490 drug applications between 31 October 2026 and 6 November 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 66, covering 52 drug names.
2026/10/31 – 2026/11/06
- New acceptances this week
- 490
- Drugs with new generic filings (by drug name, de-duplicated)
- 52
- Accepted this week, now under review
- 490
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
490filings, 66 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 255 |
| New drug | 115 |
| Generic | 66 |
| Import | 39 |
| Import re-registration | 14 |
| Unspecified | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 241 |
| TCM | 141 |
| Therapeutic biologic | 99 |
| 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 | Piperacillin Sodium for Injection | 3 | 1 | 16 |
| 2 | Metformin Hydrochloride Extended-release Tablets | 3 | 1 | 10 |
| 3 | Edaravone and Dexborneol Concentrated Solution for Injection | 2 | 2 | 34 |
| 4 | Dotinurad Tablets | 2 | 1 | 55 |
| 5 | Oxaliplatin Injection | 2 | 1 | 4 |
| 6 | 对乙酰氨基酚颗粒 · No verified English name | 2 | 1 | 2 |
| 7 | 帕拉米韦氯化钠注射液 · No verified English name | 2 | 1 | 17 |
| 8 | 注射用盐酸地尔硫? · No verified English nameThe source text contains a character that cannot be displayed. | 2 | 1 | 9 |
| 9 | 注射用磷酸左奥硝唑酯二钠 · No verified English name | 2 | 1 | 22 |
| 10 | Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules | 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
283 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Amgen Inc. | 12 | 3 | 0 |
| 2 | AstraZeneca AB | 9 | 4 | 0 |
| 3 | Sichuan Xin Da Kang Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 4 | Pfizer Inc. | 7 | 4 | 0 |
| 5 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 7 | 4 | 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 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 9 | MyoKardia Inc. | 5 | 1 | 0 |
| 10 | Novo Nordisk A/S | 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
- 481
- Left the under-review list this week
- 569
Of these, NMPA published approval-document delivery for 346 (including 327 supplemental applications, not counted as new marketing approvals) and notification delivery for 21; the outcome of the other 202 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 | Novo Nordisk A/S | 8 | 2 |
| 3 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 7 | 7 |
| 4 | Topfond Pharmaceutical Co., Ltd. | 6 | 6 |
| 5 | Hubei Dong Xin Pharma Co., Ltd. romanized | 6 | 6 |
| 6 | Guangzhou Nuo Jin Pharmaceutical Co., Ltd. romanized | 6 | 5 |
| 7 | AstraZeneca AB | 6 | 4 |
| 8 | Jiao Zuo Fu Rui Tang Pharmaceutical Co., Ltd. romanized | 5 | 5 |
| 9 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized | 5 | 2 |
| 10 | Shanghai Lei Yun Shang Pharma Co., Ltd. romanized | 4 | 4 |
Most filings entering review, by company
| # | Company (first applicant) | Filings | Drugs |
|---|---|---|---|
| 1 | Amgen Inc. | 12 | 3 |
| 2 | Eli Lilly and Company | 9 | 1 |
| 3 | Sichuan Xin Da Kang Pharma Co., Ltd. romanized | 7 | 7 |
| 4 | AstraZeneca AB | 7 | 4 |
| 5 | Fresenius Kabi AB | 7 | 2 |
| 6 | Hebei Wan Sui Pharma Co., Ltd. romanized | 6 | 6 |
| 7 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 6 | 6 |
| 8 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 6 | 3 |
| 9 | MUNDIPHARMA GmbH | 6 | 1 |
| 10 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 |
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
173 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/11/06Generic · Class 3 | 罗沙司他片 · No verified English nameCYHS2602731 | Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized |
| 2026/11/06Generic · Class 3 | Potassium Chloride InjectionCYHS2602728 | Zhejiang Guo Jing Pharma Co., Ltd. romanized |
| 2026/11/06Generic · Class 3 | Folic Acid TabletsCYHS2602725 | Kunming Yuan Rui Pharmaceutical Co., Ltd. romanized |
| 2026/11/06Generic · Class 3 | Lidocaine and Prilocaine Periodontal GelCYHL2600127 | Beijing Zhong Tai Bang Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/11/06New drug · Class 3.4 | 治疗用卡介苗 · No verified English nameCXSS2600186 | Chengdu Ke En Bio Technology Co., Ltd. romanized |
| 2026/11/06New drug · Class 1 | SPGL008注射液 · No verified English nameCXSL2601238 | Shenzhen Sai Bao Er Bio Pharma Co., Ltd. romanized |
| 2026/11/06New drug · Class 1 | 注射用HBT-708 · No verified English nameCXSL2601237 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/11/06New drug · Class 1 | GR2303注射液 · No verified English nameCXSL2601236 | Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized |
| 2026/11/06New drug · Class 1 | GR2303注射液 · No verified English nameCXSL2601235 | Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized |
| 2026/11/06New drug · Class 2.4 | 注射用重组A型肉毒毒素(Sf9细胞,150 kD天然氨基酸序列) · No verified English nameCXSL2601234 | Suzhou Ruo Yi Bio Technology Co., Ltd. romanized |
| 2026/11/06New drug · Class 1 | YH601软膏 · No verified English nameCXHL2601381 | Hangzhou Yu Hong Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/11/06New drug · Class 1 | YH601软膏 · No verified English nameCXHL2601380 | Hangzhou Yu Hong Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/11/06New drug · Class 1 | LNK01001缓释片 · No verified English nameCXHL2601379 | Ling Ke Pharma (Zhejiang) Co., Ltd. romanized |
| 2026/11/06New drug · Class 1 | SNH-126988胶囊 · No verified English nameCXHL2601378 | Sai Nuo Ha Bo Pharma (Chengdu) Co., Ltd. romanized |
| 2026/11/06New drug · Class 1 | SNH-126988胶囊 · No verified English nameCXHL2601377 | Sai Nuo Ha Bo Pharma (Chengdu) Co., Ltd. romanized |
| 2026/11/06New drug · Class 1 | SNH-126988胶囊 · No verified English nameCXHL2601376 | Sai Nuo Ha Bo Pharma (Chengdu) Co., Ltd. romanized |
| 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. |
143 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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