YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 486 drug applications between 21 September 2024 and 27 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 142, covering 100 drug names.
2024/09/21 – 2024/09/27
- New acceptances this week
- 486
- Drugs with new generic filings (by drug name, de-duplicated)
- 100
- Accepted this week, now under review
- 13
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
486filings, 142 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 184 |
| Generic | 142 |
| New drug | 81 |
| Import | 36 |
| Unspecified | 32 |
| Import re-registration | 10 |
| Drug-device combination | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 302 |
| Therapeutic biologic | 77 |
| TCM | 73 |
| Biologic | 26 |
| Prophylactic biologic | 8 |
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
100 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Brexpiprazole Tablets | 6 | 2 | 31 |
| 2 | Fentanyl Citrate Buccal Tablets | 6 | 1 | 0 |
| 3 | Cefoperazone Sodium and Sulbactam Sodium for Injection | 6 | 1 | 14 |
| 4 | Dapagliflozin Tablets | 3 | 2 | 84 |
| 5 | Carbamazepine Sustained-Release Tablets(II) | 3 | 1 | 0 |
| 6 | Brexpiprazole Orally Disintegrating Tablets | 3 | 1 | 10 |
| 7 | Amoxicillin Sodium and Sulbactam Sodium for Injection | 3 | 1 | 7 |
| 8 | Procaterol Hydrochloride Granules | 3 | 1 | 2 |
| 9 | Ethyl Iosapentate Capsules | 2 | 2 | 27 |
| 10 | Tadalafil Tablets | 2 | 2 | 23 |
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
286 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novo Nordisk A/S | 15 | 6 | 0 |
| 2 | Amgen Inc. | 9 | 2 | 0 |
| 3 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 9 | 2 | 9 |
| 4 | Guo Yao Group Kunming Xue Ye Zhi Pin Co., Ltd. romanized | 7 | 3 | 0 |
| 5 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 7 | 2 | 0 |
| 6 | Zhejiang Wo Wu Bio Technology Co., Ltd. romanized | 7 | 1 | 0 |
| 7 | Jiangxi Xing Lin Bai Ma Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 8 | AstraZeneca AB | 6 | 3 | 0 |
| 9 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized | 6 | 3 | 0 |
| 10 | Janssen-Cilag International NV | 6 | 2 | 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
176 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/09/27Import · Class 1 | MEDI5752 · No verified English nameJXSL2400185 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/27Import · Class 1 | AZD2936 · No verified English nameJXSL2400184 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/27Import · Class 2.2 | DS-8201a · No verified English nameJXSL2400183 | AstraZeneca AB; AstraZeneca Investment (China) Co. Limited |
| 2024/09/27Import · Class 1 | 镥[177Lu]依多曲肽注射液 · No verified English nameJXHL2400238 | ITM Solucin GmbH; Grand Pharmaceutical (China) Co. Ltd. |
| 2024/09/27Generic · Class 3 | Sodium Acetate Ringer's InjectionCYHS2403272 | Xian Jing Xi Shuang He Pharma Co., Ltd. romanized |
| 2024/09/27Generic · Class 3 | 奥美拉唑碳酸氢钠干混悬剂(I) · No verified English nameCYHS2403271 | Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized |
| 2024/09/27Generic · Class 3 | Vardenafil Hydrochloride Orally disintegrating TabletsCYHS2403265 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2024/09/27Generic · Class 3 | 复方聚乙二醇电解质散(儿童型) · No verified English nameCYHS2403264 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2024/09/27Generic · Class 3 | 盐酸舍曲林口服浓缩液 · No verified English nameCYHS2403263 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2024/09/27New drug · Class 1 | KJ015注射液(皮下注射) · No verified English nameCXSL2400672 | Shanghai Bao Ji Pharma Co., Ltd. romanized |
| 2024/09/27New drug · Class 3.4 | 治疗用重组卡介苗 · No verified English nameCXSL2400671 | Chengdu An Yong Ding Ye Bio Technology Co., Ltd. romanized |
| 2024/09/27New drug · Class 2.4 | 重组人透明质酸酶注射液 · No verified English nameCXSL2400670 | Beijing Nuo Bo Te Bio Technology Co., Ltd. romanized |
| 2024/09/27New drug · Class 2.4 | 重组人透明质酸酶注射液 · No verified English nameCXSL2400669 | Beijing Nuo Bo Te Bio Technology Co., Ltd. romanized |
| 2024/09/27New drug · Class 2.2 | SBK010口服溶液 · No verified English nameCXHS2400099 | Jin Zhou Ao Hong Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized |
| 2024/09/27New drug · Class 1 | 伊匹乌肽滴鼻剂 · No verified English nameCXHL2401019 | Yi Cheng Kang Tai (Xiamen) Bio Technology Co., Ltd. romanized |
| 2024/09/27New drug · Class 1 | HRS-4357注射液 · No verified English nameCXHL2401018 | Tianjin Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/09/27New drug · Class 2.2 | 注射用JMX-2006 · No verified English nameCXHL2401017 | Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanized |
| 2024/09/27New drug · Class 2.2; 2.4 | 盐酸戊乙奎醚吸入溶液 · No verified English nameCXHL2401016 | Chongqing Xian Yang Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/09/27New drug · Class 2.2; 2.4 | 盐酸戊乙奎醚吸入溶液 · No verified English nameCXHL2401015 | Chongqing Xian Yang Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/09/27New drug · Class 1 | TBA片 · No verified English nameCXHL2401014 | Guangdong Gu Mai Di Health Technology Co., Ltd. romanized; Bo Ji Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/09/27New drug · Class 1 | TBA片 · No verified English nameCXHL2401013 | Guangdong Gu Mai Di Health Technology Co., Ltd. romanized; Bo Ji Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/09/27New drug · Class 1 | TBA片 · No verified English nameCXHL2401012 | Guangdong Gu Mai Di Health Technology Co., Ltd. romanized; Bo Ji Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/09/26Import · Class 1 | PF-08046047 · No verified English nameJXSL2400182 | Seagen Inc.; Pfizer Investment CO. Ltd. |
| 2024/09/26Import · Class 1 | JNJ-81201887 (AAVCAGsCD59) · No verified English nameJXSL2400181 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/09/26Import · Class 1 | JNJ-81201887 (AAVCAGsCD59) · No verified English nameJXSL2400180 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/09/26Import · Class 1 | E7386 · No verified English nameJXHL2400237 | Eisai Co. Ltd. |
| 2024/09/26Import · Class 1 | E7386 · No verified English nameJXHL2400236 | Eisai Co. Ltd. |
| 2024/09/26Import · Class 1 | E7386 · No verified English nameJXHL2400235 | Eisai Co. Ltd. |
| 2024/09/26Generic · Class 3 | Aceclofenac TabletsCYHS2403261 | Guangdong Jun Kang Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/09/26Generic · Class 3 | Minodronic acid TabletsCYHS2403258 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
146 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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