YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 526 drug applications between 7 October 2026 and 13 October 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 91, covering 60 drug names.
2026/10/07 – 2026/10/13
- New acceptances this week
- 526
- Drugs with new generic filings (by drug name, de-duplicated)
- 60
- Accepted this week, now under review
- 469
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
526filings, 91 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 275 |
| New drug | 101 |
| Generic | 91 |
| Import | 32 |
| Import re-registration | 18 |
| Unspecified | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 278 |
| TCM | 147 |
| Therapeutic biologic | 99 |
| Biologic | 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
60 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 | Sacubitril Valsartan Sodium Tablets | 4 | 2 | 70 |
| 3 | Allopurinol Tablets | 3 | 2 | 4 |
| 4 | Brivaracetam Tablets | 3 | 2 | 19 |
| 5 | Ixazomib Citrate Capsules | 3 | 1 | 7 |
| 6 | Dihydrocodeine Tartrate Sustained Realese Tablets | 3 | 1 | 3 |
| 7 | 二硫化硒洗剂 · No verified English name | 2 | 2 | 14 |
| 8 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 9 | Mupirocin Ointment | 2 | 2 | 30 |
| 10 | Emedastine Difumarate Sustained-release Capsules | 2 | 1 | 11 |
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
295 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Dong E E Jiao Co., Ltd. romanized | 11 | 11 | 0 |
| 2 | Pfizer Inc. | 9 | 2 | 0 |
| 3 | Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized | 8 | 2 | 0 |
| 4 | N. V. Organon | 8 | 1 | 0 |
| 5 | Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized | 7 | 7 | 0 |
| 6 | Boehringer Ingelheim International GmbH | 7 | 1 | 0 |
| 7 | Guangxi Bao Rui Tan Pharmaceutical Co., Ltd. romanized | 6 | 4 | 0 |
| 8 | Upjohn Manufacturing Ireland Unlimited Company | 6 | 1 | 0 |
| 9 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 10 | Mian Yang Yi Kang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 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
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
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
172 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/10/13Import · Class 3.1 | 尼塔奇单抗注射液(皮下注射) · No verified English nameJXSS2600094 | Joint Stock Company “BIOCAD”(JSC “BIOCAD”); Gen8 (SH) Limited |
| 2026/10/13Import · Class 2.2 | 瑞利珠单抗注射液 · No verified English nameJXSS2600093 | Alexion Europe SAS; Alexion Pharma International Operations Limited; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/10/13Import · Class 2.2 | 瑞利珠单抗注射液 · No verified English nameJXSS2600092 | Alexion Europe SAS; Alexion Pharma International Operations Limited; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/10/13Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2600448 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd |
| 2026/10/13Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2600447 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd |
| 2026/10/13Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2600446 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd |
| 2026/10/13Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2600445 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd |
| 2026/10/13Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2600444 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd |
| 2026/10/13Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2600443 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd |
| 2026/10/13Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2600442 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd |
| 2026/10/13Import · Class 1 | GVV858 · No verified English nameJXHL2600441 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/10/13Generic · Class 3 | Cetylpyridinium Chloride Buccal TabletsCYHS2602521 | Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2026/10/13Generic · Class 3 | Glycopyrrolate InjectionCYHS2602516 | Henan Pu Rui Pharma Co., Ltd. romanized |
| 2026/10/13Generic · Class 3 | Glycopyrrolate InjectionCYHS2602515 | Henan Pu Rui Pharma Co., Ltd. romanized |
| 2026/10/13Generic · Class 3 | Benzbromarone TabletsCYHS2602511 | Suzhou Di San Pharmaceutical Factory Co., Ltd. romanized |
| 2026/10/13Generic · Class 3 | 中性腹膜透析液(乳酸盐-G2.5%) · No verified English nameCYHS2602509 | Jiangsu Jie Rui Medical Technology Co., Ltd. romanized; Shandong Hua Mao Pharma Co., Ltd. romanized |
| 2026/10/13Generic · Class 3 | 中性腹膜透析液(乳酸盐-G1.5%) · No verified English nameCYHS2602508 | Jiangsu Jie Rui Medical Technology Co., Ltd. romanized; Shandong Hua Mao Pharma Co., Ltd. romanized |
| 2026/10/13Generic · Class 3 | Brivaracetam TabletsCYHS2602507 | Xi Nan Pharma Co., Ltd. romanized |
| 2026/10/13Generic · Class 3 | Acetylcysteine TabletsCYHS2602506 | Jiangxi Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized |
| 2026/10/13New drug · Class 1 | AI-081注射液 · No verified English nameCXSL2601114 | Nanjing Ang Ke Mian Yi Biopharmaceuticals Co., Ltd. romanized |
| 2026/10/13New drug · Class 1 | AI-081注射液 · No verified English nameCXSL2601113 | Nanjing Ang Ke Mian Yi Biopharmaceuticals Co., Ltd. romanized |
| 2026/10/13New drug · Class 1 | IMC-003 · No verified English nameCXSL2601112 | Yi Ming Kai Er Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/10/13New drug · Class 1 | SHR-6129注射液 · No verified English nameCXSL2601111 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/10/13New drug · Class 1 | SI-B001双特异性抗体注射液 · No verified English nameCXSL2601110 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2026/10/13New drug · Class 2.2 | 注射用BL-B01D1 · No verified English nameCXSL2601109 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2026/10/13New drug · Class 1 | SIBP-A21注射液 · No verified English nameCXSL2601108 | Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2026/10/13New drug · Class 1 | 注射用TJ101 · No verified English nameCXSL2601107 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2026/10/13New drug · Class 2.4 | 贝泽昔替尼片 · No verified English nameCXHS2600139 | Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized; Shandong Yao Shi Pharma Co., Ltd. romanized |
| 2026/10/13New drug · Class 2.4 | 贝泽昔替尼片 · No verified English nameCXHS2600138 | Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized; Shandong Yao Shi Pharma Co., Ltd. romanized |
| 2026/10/13New drug · Class 1 | BGB-58067片 · No verified English nameCXHL2601276 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
142 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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