YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 97 drug applications between 4 October 2024 and 10 October 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 26, covering 22 drug names.
2024/10/04 – 2024/10/10
- New acceptances this week
- 97
- Drugs with new generic filings (by drug name, de-duplicated)
- 22
- Accepted this week, now under review
- 1
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
97filings, 26 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 46 |
| Generic | 26 |
| New drug | 13 |
| Import | 6 |
| Unspecified | 4 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 60 |
| Therapeutic biologic | 21 |
| TCM | 13 |
| Biologic | 2 |
| Prophylactic biologic | 1 |
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
22 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | ω-3 Fish Oil Fat Emulsion Injection | 2 | 1 | 6 |
| 2 | Piracetam Injection | 2 | 1 | 9 |
| 3 | Sodium Hyaluronate Eye Drops | 2 | 1 | 30 |
| 4 | Dopamine Hydrochloride Injection | 2 | 1 | 3 |
| 5 | Ethyl Iosapentate Capsules | 1 | 1 | 27 |
| 6 | Linaclotide Capsules | 1 | 1 | 13 |
| 7 | Carbazochrome Sodium Sulfonate Injection | 1 | 1 | 1 |
| 8 | Celecoxib Capsules | 1 | 1 | 5 |
| 9 | Potassium Phosphates Injection | 1 | 1 | 2 |
| 10 | Fusidic Acid Cream | 1 | 1 | 15 |
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
71 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Eli Lilly and Company | 5 | 2 | 0 |
| 2 | Bristol-Myers Squibb Pharma EEIG | 4 | 1 | 0 |
| 3 | Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized | 3 | 2 | 3 |
| 4 | Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized | 3 | 2 | 0 |
| 5 | Janssen-Cilag International NV | 2 | 2 | 0 |
| 6 | Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized | 2 | 2 | 0 |
| 7 | Chongqing Xi Er An Pharma Co., Ltd. romanized | 2 | 2 | 0 |
| 8 | Qilu Pharmaceutical Co., Ltd. | 2 | 2 | 0 |
| 9 | Chiesi Farmaceutici S.p.A. | 2 | 1 | 0 |
| 10 | Jenapharm GmbH & Co. KG | 2 | 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
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
30 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/10/10Generic · Class 3 | Potassium Phosphates InjectionCYHS2403354 | Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/10/10Generic · Class 3 | Polymyxin B sulfate for InjectionCYHS2403351 | Yao Su (Shanghai) Medical Technology Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized |
| 2024/10/10Generic · Class 3 | Doxercalciferol InjectionCYHS2403349 | Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized |
| 2024/10/10Generic · Class 3 | Piracetam InjectionCYHS2403348 | Shandong Li Nuo Pharmaceutical Co., Ltd. romanized; Shandong Fang Ming Pharma Group Co., Ltd. romanized |
| 2024/10/10Generic · Class 3 | Piracetam InjectionCYHS2403347 | Shandong Li Nuo Pharmaceutical Co., Ltd. romanized; Shandong Fang Ming Pharma Group Co., Ltd. romanized |
| 2024/10/10Generic · Class 3 | Carbazochrome Sodium Sulfonate InjectionCYHS2403345 | Anhui Bo Nuo Mei Ke Biopharmaceuticals Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized |
| 2024/10/10New drug · Class 3.1 | 桃红四物颗粒 · No verified English nameCXZS2400033 | Shen Wei Pharma Group Co., Ltd. romanized |
| 2024/10/10New drug · Class 1 | 注射用MHB039A · No verified English nameCXSL2400680 | Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2024/10/10New drug · Class 1 | 注射用MHB036C · No verified English nameCXSL2400679 | Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2024/10/10New drug · Class 1 | 注射用MHB036C · No verified English nameCXSL2400678 | Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2024/10/10New drug · Class 1 | 注射用SHR-1681 · No verified English nameCXSL2400677 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2024/10/10New drug · Class 1 | TAN-118片 · No verified English nameCXHL2401039 | Shanghai Ze De Man Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/10/10New drug · Class 1 | TAN-118片 · No verified English nameCXHL2401038 | Shanghai Ze De Man Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/10/09Import · Class 2.2 | 米吉珠单抗注射液(皮下注射) · No verified English nameJXSS2400083 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/10/09Import · Class 2.2 | 米吉珠单抗注射液(皮下注射) · No verified English nameJXSS2400082 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/10/09Import · Class 2.2 | 米吉珠单抗注射液(皮下注射) · No verified English nameJXSS2400081 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/10/09Import · Class 2.2 | 米吉珠单抗注射液(皮下注射) · No verified English nameJXSS2400080 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/10/09Import · Class 2.2 | 米吉珠单抗注射液 · No verified English nameJXSS2400079 | Eli Lilly and Company; BSP PHARMACEUTICALS S.P.A.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/10/09Import · Class 1 | VHB937注射用浓溶液 · No verified English nameJXSL2400190 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/10/09Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2403343 | Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized |
| 2024/10/09Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2403342 | Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized |
| 2024/10/09Generic · Class 3 | Aminocaproic Acid InjectionCYHS2403337 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized |
| 2024/10/09Generic · Class 3 | Chlorphenamine Maleate InjectionCYHS2403333 | Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized |
| 2024/10/09Generic · Class 3 | Potassium Chloride Oral SolutionCYHS2403332 | Jiangxi Bo Tai Pharma Co., Ltd. romanized; Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized |
| 2024/10/09New drug · Class 1.1 | 柴金散结颗粒 · No verified English nameCXZL2400064 | Guangdong Kai Zhong Bio Technology Co., Ltd. romanized |
| 2024/10/09New drug · Class 3.4 | 人纤维蛋白原 · No verified English nameCXSS2400108 | Tong Lu Biopharmaceutical Co., Ltd. romanized |
| 2024/10/09New drug · Class 3.3 | 冻干b型流感嗜血杆菌结合疫苗 · No verified English nameCXSL2400676 | Changchun Bai Ke Bio Technology Shareholding Company romanized |
| 2024/10/09New drug · Class 2.2 | 1646A干混悬剂 · No verified English nameCXHL2401037 | Pu Zhao Guo Kang (Hubei) Pharma Co., Ltd. romanized |
| 2024/10/09New drug · Class 1 | [177Lu]Lu-XT117注射液 · No verified English nameCXHL2401036 | Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/10/08New drug · Class 1 | JKN2403片 · No verified English nameCXHL2401035 | Health Yuan Pharma Group Co., Ltd. romanized |
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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