YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 392 drug applications between 28 October 2026 and 3 November 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 57, covering 40 drug names.
2026/10/28 – 2026/11/03
- New acceptances this week
- 392
- Drugs with new generic filings (by drug name, de-duplicated)
- 40
- Accepted this week, now under review
- 392
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
392filings, 57 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 196 |
| New drug | 97 |
| Generic | 57 |
| Import | 29 |
| Import re-registration | 11 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 186 |
| TCM | 121 |
| Therapeutic biologic | 81 |
| Prophylactic biologic | 4 |
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
40 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 氟比洛芬凝胶贴膏 · No verified English name | 3 | 3 | 16 |
| 2 | 氧 · No verified English name | 3 | 3 | 15 |
| 3 | Vortioxetine Hydrobromide Tablets | 3 | 1 | 10 |
| 4 | Oseltamivir Phosphate Capsules | 3 | 1 | 39 |
| 5 | Polidocanol Injection | 3 | 1 | 23 |
| 6 | Emedastine Difumarate Eye Drops | 2 | 2 | 9 |
| 7 | 环孢素滴眼液(Ⅲ) · No verified English name | 2 | 2 | 9 |
| 8 | Ezetimibe and Atorvastatin Calcium Trihydrate Tablets | 2 | 1 | 4 |
| 9 | 复方氨基酸注射液(17AA-SF) · No verified English name | 2 | 1 | 4 |
| 10 | 复方电解质维持液 · No verified English name | 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
226 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AstraZeneca AB | 10 | 5 | 0 |
| 2 | Eli Lilly and Company | 9 | 1 | 0 |
| 3 | Sichuan Xin Da Kang Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 4 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 7 | 6 | 0 |
| 5 | Fresenius Kabi AB | 7 | 2 | 0 |
| 6 | Hebei Wan Sui Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | Sichuan Qi Li Pharmaceutical Co., Ltd. romanized | 6 | 5 | 0 |
| 8 | MUNDIPHARMA GmbH | 6 | 1 | 0 |
| 9 | Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized | 6 | 1 | 0 |
| 10 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized | 5 | 3 | 2 |
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
- 372
- Left the under-review list this week
- 401
Of these, NMPA published approval-document delivery for 176 (including 172 supplemental applications, not counted as new marketing approvals) and notification delivery for 8; the outcome of the other 217 is to be checked.
Most filings leaving review, by company
| # | Company (first applicant) | Filings | Drugs |
|---|---|---|---|
| 1 | Novo Nordisk A/S | 15 | 2 |
| 2 | Shanghai Min Wei Bio Technology Co., Ltd. romanized | 11 | 1 |
| 3 | Beijing Bao Shu Tang Technology Pharma Co., Ltd. romanized | 10 | 10 |
| 4 | Eli Lilly Nederland B.V. | 8 | 2 |
| 5 | Xin Da Bio Technology Co., Ltd. romanized | 8 | 1 |
| 6 | Hainan Ai Ke Pharmaceutical Co., Ltd. romanized | 5 | 5 |
| 7 | Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized | 5 | 5 |
| 8 | Pfizer Europe MA EEIG | 5 | 3 |
| 9 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 4 | 4 |
| 10 | Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized | 4 | 2 |
Most filings entering review, by company
| # | Company (first applicant) | Filings | Drugs |
|---|---|---|---|
| 1 | Eli Lilly and Company | 9 | 1 |
| 2 | Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized | 7 | 3 |
| 3 | Fresenius Kabi AB | 7 | 2 |
| 4 | Hebei Wan Sui Pharma Co., Ltd. romanized | 6 | 6 |
| 5 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 6 | 6 |
| 6 | Sichuan Qi Li Pharmaceutical Co., Ltd. romanized | 6 | 5 |
| 7 | MUNDIPHARMA GmbH | 6 | 1 |
| 8 | Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized | 6 | 1 |
| 9 | AstraZeneca AB | 5 | 3 |
| 10 | Nanjing En Tai Pharmaceuticals Technology 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
139 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/11/03Import · Class 1 | AZD0486 · No verified English nameJXSL2600294 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/11/03Import · Class 1 | AZD0486 · No verified English nameJXSL2600293 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/11/03Import · Class 1 | AZD5492 · No verified English nameJXSL2600292 | AstraZeneca AB; AstraZeneca Global ll&U (China) Co. Ltd. |
| 2026/11/03Import · Class 1 | AZD3470薄膜衣片 · No verified English nameJXHL2600482 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/11/03Import · Class 1 | AZD3470薄膜衣片 · No verified English nameJXHL2600481 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/11/03Generic · Class 3 | Pregabalin Extended release TabletsCYHS2602684 | Chongqing De Run Sheng Pharmaceuticals Co., Ltd. romanized; Chongqing Huapont Pharmaceutical Co., Ltd. |
| 2026/11/03Generic · Class 3 | Pioglitazone and Metformin Hydrochloride TabletsCYHS2602682 | Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized |
| 2026/11/03Generic · Class 3 | 对乙酰氨基酚颗粒 · No verified English nameCYHS2602680 | Shijiazhuang Gree Pharmaceutical Co., Ltd |
| 2026/11/03Generic · Class 3 | 对乙酰氨基酚颗粒 · No verified English nameCYHS2602679 | Shijiazhuang Gree Pharmaceutical Co., Ltd |
| 2026/11/03New drug · Class 1.1 | 芩椒颗粒 · No verified English nameCXZL2600112 | Sichuan Ji Sheng Tang Pharma Co., Ltd. romanized |
| 2026/11/03New drug · Class 1.1 | 七妙颗粒 · No verified English nameCXZL2600111 | Nanjing Rong Yu Pharmaceuticals Industry Co., Ltd. romanized; Nanjing Zhong Pharmaceuticals University romanized |
| 2026/11/03New drug · Class 1 | 奥美妥塔单抗注射液 · No verified English nameCXSS2600184 | Jiangsu Ao Sai Kang Biopharmaceuticals Co., Ltd. romanized; Yan Tai Mai Bai Rui International Biopharmaceuticals Co., Ltd. romanized |
| 2026/11/03New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2600183 | Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized; Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized |
| 2026/11/03New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2600182 | Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized; Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized |
| 2026/11/03New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2600181 | Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized; Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized |
| 2026/11/03New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2600180 | Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized; Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized |
| 2026/11/03New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2600179 | Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized; Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized |
| 2026/11/03New drug · Class 1 | KSD-101注射液 · No verified English nameCXSL2601217 | Shanghai Heng Sai Bio Technology Co., Ltd. romanized |
| 2026/11/03New drug · Class 1 | BNT326 · No verified English nameCXSL2601216 | Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized; Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized |
| 2026/11/03New drug · Class 1 | Gotistobart注射液 · No verified English nameCXSL2601215 | Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2026/11/03New drug · Class 1 | SHR-4610注射液 · No verified English nameCXSL2601214 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/11/03New drug · Class 1 | SYS6043 · No verified English nameCXSL2601213 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2026/11/03New drug · Class 2.2 | 注射用瑞康曲妥珠单抗 · No verified English nameCXSL2601212 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/11/03New drug · Class 1 | CC312冻干粉针剂 · No verified English nameCXSL2601211 | Hui He Bio Technology (Shanghai) Co., Ltd. romanized |
| 2026/11/03New drug · Class 1 | UMSC01细胞注射液 · No verified English nameCXSL2601210 | Shanghai Jiu Qian Cheng Biopharmaceuticals Co., Ltd. romanized |
| 2026/11/03New drug · Class 1 | SHR-5439注射液 · No verified English nameCXSL2601209 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/11/03New drug · Class 1 | SHR-4610注射液 · No verified English nameCXSL2601208 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/11/03New drug · Class 1 | 注射用HS-20122 · No verified English nameCXSL2601207 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2026/11/03New drug · Class 1 | 普美昔替尼鼻喷雾剂 · No verified English nameCXHS2600146 | Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized; Chi Feng Sai Lin Tai Pharma Co., Ltd. romanized |
| 2026/11/03New drug · Class 1 | IMP9064片 · No verified English nameCXHL2601356 | Nanjing Ying Pai Pharma Co., Ltd. romanized |
109 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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